A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03607422
- Lead Sponsor
- AbbVie
- Brief Summary
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
- Detailed Description
This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit.
Participants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of a minimum of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled overall (main study + adolescent sub-study).
Randomization in the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of moderate \[3\] versus severe \[4\]), by geographic region (United States \[US\]/Puerto Rico/Canada, and Other), and by age (adolescent \[ages 12 to 17\] versus adult \[ages 18 to 75\]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate \[vIGA-AD = 3\] vs. severe \[vIGA-AD = 4\]) and by geographic region (US/Puerto Rico/Canada and Other).
At Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index \[EASI 50\] responder \[Yes/No\], geographic region \[US/Puerto Rico/Canada, and other\], and age group \[adolescent/adult\]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other). Participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose.
Starting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary.
The Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 912
- Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
- Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current AD treatments prior to the study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo / Upadacitinib Placebo for Upadacitinib Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Placebo / Upadacitinib Upadacitinib Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260. Upadacitinib 15 mg QD Upadacitinib Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Upadacitinib 30 mg QD Upadacitinib Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.
- Primary Outcome Measures
Name Time Method Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 Baseline and Week 16 The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
* 0 - Clear: No inflammatory signs of AD;
* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification, no oozing or crusting;
* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification, no oozing or crusting;
* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
- Secondary Outcome Measures
Name Time Method Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 Baseline (last available rolling average before the first dose of study drug) and Week 4 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 Baseline and Week 2 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 Baseline (last available rolling average before the first dose of study drug) and Week 1 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2 Baseline and Day 2 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11- point scale from 0 (no itch) to 10 (worst imaginable itch). The percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3 Baseline and Day 3 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
The percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period From first dose of study drug to Week 16 A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD.
The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.
The minimal clinically important difference for ADerm-IS sleep domain score is 12.Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16 Baseline and Week 16 The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.
Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16 Baseline and Week 16 The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS emotional state sums three items \[Items 8-10\] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.
The minimal clinically important difference for ADerm-IS emotional state domain score is 11.Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16 Baseline and Week 16 The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS Daily Activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.
The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
Main Study: Percent Change From Baseline in EASI Score at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1)\] moderate \[2\], or severe \[3\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16 Baseline and Week 16 The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults.
Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Baseline and Week 16 The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16 Baseline and Week 16 SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16 Week 16 The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2 Baseline and Week 2 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3 Baseline and Day 3 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16 Baseline and Week 16 The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16 Week 16 The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16 Week 16 The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
The DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 Baseline and Week 16 The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
* 0 - Clear: No signs of AD;
* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification, no oozing or crusting;;
* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification, no oozing or crusting;
* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 Baseline (last available rolling average before the first dose of study drug) and Week 1 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2 Baseline and Day 2 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period From first dose of study drug to Week 16 A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain).
The minimal clinically important difference for ADerm-SS skin pain score is 4. The ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 Baseline (last available rolling average before the first dose of study drug) and Week 4 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD.
The ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.
The minimal clinically important difference for ADerm-IS sleep domain score is 12.Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16 Baseline (last available rolling average before the first dose of study drug) and Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16 Baseline and Week 16 The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16 Week 16 The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.
the DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16 Baseline and Week 16 The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.
Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16 Baseline and Week 16 The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.
The minimal clinically important difference for the ADerm-IS daily activities domain score is 14.Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
An EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.Adolescents: Percent Change From Baseline in EASI Score at Week 16 Baseline and Week 16 EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1)\] moderate \[2\], or severe \[3\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16 Baseline and Week 16 The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.
ADerm-IS emotional state sums three items \[Items 8-10\] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.
The minimal clinically important difference for ADerm-IS emotional state domain score is 11.Adolescents: Percent Change From Baseline in SCORAD Score at Week 16 Baseline and Week 16 SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Trial Locations
- Locations (196)
Dermatology Treatment and Research Center, PA /ID# 205473
🇺🇸Dallas, Texas, United States
Arkansas Research Trials /ID# 218469
🇺🇸North Little Rock, Arkansas, United States
Floridian Clinical Research /ID# 207433
🇺🇸Miami Lakes, Florida, United States
Southside Dermatology /ID# 214451
🇺🇸Tulsa, Oklahoma, United States
Ashira Dermatology /ID# 205512
🇺🇸Gurnee, Illinois, United States
Care Access Research /ID# 218476
🇺🇸Hoboken, New Jersey, United States
Bellaire Dermatology /ID# 205470
🇺🇸Bellaire, Texas, United States
Epiphany Dermatology - Fort Worth /ID# 210073
🇺🇸Fort Worth, Texas, United States
Raga Clinical Studies, LLC. /ID# 206749
🇺🇸Crown Point, Indiana, United States
Ordensklinikum Linz GmbH Elisabethinen /ID# 206573
🇦🇹Linz, Oberoesterreich, Austria
Allergy, Asthma & Immunology Associates, PC /ID# 218169
🇺🇸Lincoln, Nebraska, United States
Vital Prospects Clinical Research Institute, PC /ID# 205824
🇺🇸Tulsa, Oklahoma, United States
Clinical Investigation Specialists, Inc. /ID# 206898
🇺🇸Gurnee, Illinois, United States
Skin Laser and Surgery Specialists of NY and NJ /ID# 206754
🇺🇸Hackensack, New Jersey, United States
UZ Gent /ID# 205181
🇧🇪Gent, Oost-Vlaanderen, Belgium
Metroplex Dermatology /ID# 213307
🇺🇸Arlington, Texas, United States
Hutchinson Clinic /ID# 205970
🇺🇸Hutchinson, Kansas, United States
DermEdge Research Inc. /ID# 206036
🇨🇦Mississauga, Ontario, Canada
Allergy Research Canada Inc. /ID# 213547
🇨🇦Niagara Falls, Ontario, Canada
UCL Saint-Luc /ID# 205537
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Stones River Dermatology /ID# 205178
🇺🇸Murfreesboro, Tennessee, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135
🇺🇸Skokie, Illinois, United States
Styde Research, LLC /ID# 213469
🇺🇸Lewisville, Texas, United States
Aspen Clinical Research /ID# 208399
🇺🇸Orem, Utah, United States
Clinical Investigation Specialist, Inc - Kenosha /ID# 215933
🇺🇸Kenosha, Wisconsin, United States
The Royal Melbourne Hospital /ID# 205919
🇦🇺Parkville, Victoria, Australia
Drug Research Center /ID# 217855
🇭🇺Balatonfured, Veszprem, Hungary
251 Airforce General Hospital /ID# 205841
🇬🇷Athens, Attiki, Greece
ASST Spedali civili di Brescia /ID# 205927
🇮🇹Brescia, Italy
Haut- und Laserzentrum Hunsrück /ID# 205768
🇩🇪Simmern, Germany
Stratica Medical /ID# 205415
🇨🇦Edmonton, Alberta, Canada
Seoul National University Hospital /ID# 206396
🇰🇷Seoul, Korea, Republic of
AP-HP - Hopital Saint-Louis /ID# 206552
🇫🇷Paris, France
CHRU de Brest - Hopital Morvan /ID# 206555
🇫🇷Brest, France
Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890
🇨🇦Guelph, Ontario, Canada
Chung-Ang University Hostipal /ID# 206397
🇰🇷Seoul, Korea, Republic of
Fakultni nemocnice Plzen /ID# 205096
🇨🇿Plzen, Czechia
C.H. de Bretagne Sud /ID# 206910
🇫🇷Lorient, France
Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766
🇩🇪Witten, Germany
Fakultni Nemocnice v Motole /ID# 218192
🇨🇿Praha, Czechia
Bugat Pal Korhaz /ID# 211247
🇭🇺Gyöngyös, Heves, Hungary
University Hospital Waterford /ID# 204266
🇮🇪Waterford, Ireland
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767
🇩🇪Dresden, Germany
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097
🇨🇿Usti nad Labem, Czechia
CentroDerm GmbH /ID# 206861
🇩🇪Wuppertal, Germany
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611
🇭🇺Kaposvár, Somogy, Hungary
General Hospital Andreas Syggros /ID# 204527
🇬🇷Athens, Attiki, Greece
Klinikum Darmstadt /ID# 207483
🇩🇪Darmstadt, Germany
Hopital Saint-Andre /ID# 206554
🇫🇷Bordeaux, France
Sanatorium profesora Arenbergera /ID# 205098
🇨🇿Praha, Czechia
Synexus Magyarorszag Kft. /ID# 206008
🇭🇺Budapest, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085
🇭🇺Pecs, Hungary
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448
🇭🇷Ivanic-Grad, Zagrebacka Zupanija, Croatia
401 GSNA - 401 Army General Hospital /ID# 205352
🇬🇷Athens, Attiki, Greece
The Guenther Dermatology Research Centre /ID# 206772
🇨🇦London, Ontario, Canada
Hallym University Kangnam Sacred Heart Hospital /ID# 206343
🇰🇷Seoul, Korea, Republic of
Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765
🇩🇪Mahlow, Germany
Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771
🇨🇦Sudbury, Ontario, Canada
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982
🇩🇪Hamburg, Germany
Clinexpert Kft /ID# 211246
🇭🇺Budapest, Hungary
Hospital General Universitario de Valencia /ID# 210565
🇪🇸Valencia, Spain
Ajou University Hospital /ID# 206341
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Hospital Parc de Salut del Mar /ID# 204709
🇪🇸Barcelona, Spain
Vseobecna fakultni nemocnice v Praze /ID# 205201
🇨🇿Praha, Czechia
Hopital Prive d'Antony /ID# 206553
🇫🇷Antony, Ile-de-France, France
Hospital Campus de la Salud /ID# 205544
🇪🇸Granada, Spain
Northwick Park Hospital /ID# 205250
🇬🇧Middlesex, Harrow, United Kingdom
Hospital Universitario Infanta Leonor /ID# 204710
🇪🇸Madrid, Spain
Bravis Ziekenhuis /ID# 206676
🇳🇱Bergen op Zoom, Noord-Brabant, Netherlands
Universitair Medisch Centrum Groningen /ID# 205162
🇳🇱Groningen, Netherlands
Hospital Sant Joan de Deu /ID# 218047
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Clinic de Barcelona /ID# 210564
🇪🇸Barcelona, Spain
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993
🇬🇧Newcastle Upon Tyne, United Kingdom
Barts Health NHS Trust /ID# 206491
🇬🇧London, London, City Of, United Kingdom
Continental Clinical Solutions /ID# 210327
🇺🇸Towson, Maryland, United States
Great Lakes Clinical Trials /ID# 205830
🇺🇸Chicago, Illinois, United States
Rady Children's Hospital San Diego /ID# 208244
🇺🇸San Diego, California, United States
Lakes Research, LLC /ID# 209156
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute /ID# 209413
🇺🇸Miami, Florida, United States
Papageorgiou General Hospital Thessaloniki /ID# 204526
🇬🇷Stavroupoli (Thessalonikis), Thessaloniki, Greece
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658
🇩🇪Kiel, Schleswig-Holstein, Germany
Aarhus University Hospital /ID# 205524
🇩🇰Aarhus N, Midtjylland, Denmark
Sjællands Universitetshospital /ID# 205960
🇩🇰Roskilde, Sjælland, Denmark
Niakosari Medicine Professional Corporation /ID# 206004
🇨🇦Toronto, Ontario, Canada
Total Skin and Beauty Derm Ctr /ID# 205129
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialist /ID# 205516
🇺🇸Phoenix, Arizona, United States
Arizona Research Center, Inc. /ID# 205795
🇺🇸Phoenix, Arizona, United States
Skin Specialists, PC /ID# 205515
🇺🇸Omaha, Nebraska, United States
Derm Clin Res Ctr San Antonio /ID# 205469
🇺🇸San Antonio, Texas, United States
Linkou Chang Gung Memorial Ho /ID# 204783
🇨🇳Taoyuan City, Taiwan
The Dermatology Clinic of Arkansas /ID# 218749
🇺🇸Bryant, Arkansas, United States
Encino Research Center /ID# 207472
🇺🇸Encino, California, United States
University of California Irvine /ID# 205136
🇺🇸Irvine, California, United States
Wallace Medical Group /ID# 205701
🇺🇸Los Angeles, California, United States
Keck School of Medicine of USC /ID# 206971
🇺🇸Los Angeles, California, United States
Child Hosp of Orange County,CA /ID# 205735
🇺🇸Orange, California, United States
New England Research Associates, LLC /ID# 206896
🇺🇸Bridgeport, Connecticut, United States
Midflorida Clinical Research, Inc. /ID# 213700
🇺🇸Brandon, Florida, United States
Clinical Research of West Florida, Inc /ID# 206146
🇺🇸Clearwater, Florida, United States
Savin Medical Group, LLC /ID# 206902
🇺🇸Miami Lakes, Florida, United States
ForCare Clinical Research /ID# 205120
🇺🇸Tampa, Florida, United States
Complete Health Research /ID# 213459
🇺🇸Ormond Beach, Florida, United States
Advanced Research for Health Improvement /ID# 218003
🇺🇸Naples, Florida, United States
Precision Clinical Research /ID# 207364
🇺🇸Sunrise, Florida, United States
Marietta Dermatology Clinical Research /ID# 210317
🇺🇸Marietta, Georgia, United States
Agile Clinical Research Trials /ID# 218080
🇺🇸Sandy Springs, Georgia, United States
Treasure Valley Medical Research /ID# 210298
🇺🇸Boise, Idaho, United States
University Hospitals Case Medical Center /ID# 206639
🇺🇸Cleveland, Ohio, United States
Velocity Clinical Research Hallandale Beach /ID# 207544
🇺🇸Medford, Oregon, United States
Clinical Research Solutions, LLC /ID# 218416
🇺🇸Jackson, Tennessee, United States
Austin Institute for Clinical Research /ID# 206640
🇺🇸Pflugerville, Texas, United States
Sinclair Dermatology /ID# 217791
🇦🇺East Melbourne, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 206909
🇦🇹Sankt Poelten, Niederoesterreich, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281
🇦🇹Salzburg, Austria
Medical complex Doverie /ID# 211289
🇧🇬Sofia, Bulgaria
Medical center Sveti Panteleimon /ID# 210414
🇧🇬Sofia, Bulgaria
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938
🇧🇪Liege, Belgium
Skin Care Studio /ID# 205420
🇨🇦St. John's, Newfoundland and Labrador, Canada
Alberta DermaSurgery Centre /ID# 205422
🇨🇦Edmonton, Alberta, Canada
Pacific Derm /ID# 206797
🇨🇦Vancouver, British Columbia, Canada
Military Medical Academy Multiprofile Hospital /ID# 205291
🇧🇬Sofia, Bulgaria
Kingsway Clinical Research /ID# 206005
🇨🇦Etobicoke, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Center /ID# 206333
🇨🇦Barrie, Ontario, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138
🇨🇦Newmarket, Ontario, Canada
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429
🇭🇷Zagreb, Grad Zagreb, Croatia
Skinsense Medical Research /ID# 206873
🇨🇦Saskatoon, Saskatchewan, Canada
Djecja bolnica Srebrnjak /ID# 205926
🇭🇷Zagreb, Grad Zagreb, Croatia
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072
🇭🇺Miskolc, Borsod-Abauj-Zemplen, Hungary
St James Hospital /ID# 204264
🇮🇪Dublin 8, Dublin, Ireland
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986
🇮🇹Rome, Lazio, Italy
University Hospital Galway /ID# 209965
🇮🇪Galway, Ireland
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168
🇮🇹Cagliari, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 205169
🇮🇹Modena, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987
🇮🇹Rome, Lazio, Italy
Presidio Ospedaliero San Salvatore /ID# 205167
🇮🇹L'Aquila, Italy
SoonChunHyang University Buchon Hospital /ID# 206391
🇰🇷Buncheon, Gyeonggido, Korea, Republic of
Korea University Ansan Hospital /ID# 206342
🇰🇷Ansan, Gyeonggido, Korea, Republic of
The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529
🇰🇷Incheon, Korea, Republic of
Reinier de Graaf /ID# 205811
🇳🇱Delft, Netherlands
CCA Braga - Hospital de Braga /ID# 205854
🇵🇹Braga, Portugal
Centrum Oosterwal /ID# 209640
🇳🇱Alkmaar, Netherlands
Greenlane Clinical Centre /ID# 205664
🇳🇿Epsom, Auckland, New Zealand
Hospital CUF Descobertas /ID# 205431
🇵🇹Lisboa, Portugal
CHP, EPE- Hospital Geral de Sa /ID# 205187
🇵🇹Porto, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679
🇵🇹Porto, Portugal
Hospital Universitario Reina Sofia /ID# 204712
🇪🇸Cordoba, Spain
University Hospital Plymouth NHS Trust /ID# 204649
🇬🇧Plymouth, United Kingdom
Ark Clinical Research /ID# 218193
🇺🇸Long Beach, California, United States
Palmtree Clinical Research Inc. /Id# 206184
🇺🇸Palm Springs, California, United States
Southern California Derma. Inc /ID# 205734
🇺🇸Santa Ana, California, United States
Innovative Clinical Research - Lafayette /ID# 208400
🇺🇸Lafayette, Colorado, United States
Skin Care Research, LLC /ID# 207099
🇺🇸Boca Raton, Florida, United States
Advanced Research for Health Improvement /ID# 217987
🇺🇸Naples, Florida, United States
Awasty Research Network, LLC /ID# 206748
🇺🇸Marion, Ohio, United States
Hospital General Universitario Gregorio Maranon /ID# 204380
🇪🇸Madrid, Spain
Ideal Clinical Research Inc. /ID# 209880
🇺🇸Aventura, Florida, United States
Georgia Pollens Clinical Research Centers, Inc /ID# 218567
🇺🇸Albany, Georgia, United States
Hospital Infantil Universitario Nino Jesus /ID# 210437
🇪🇸Madrid, Spain
Revival Research /ID# 208383
🇺🇸Doral, Florida, United States
Universal Axon Clinical Research /ID# 213703
🇺🇸Doral, Florida, United States
Center for Clinical Studies /ID# 213186
🇺🇸Cypress, Texas, United States
Monash Children's Hospital /ID# 217917
🇦🇺Clayton, Victoria, Australia
University Hospital Southampton NHS Foundation Trust /ID# 205711
🇬🇧Southampton, Hampshire, United Kingdom
UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837
🇨🇦Vancouver, British Columbia, Canada
Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292
🇧🇬Sofia, Bulgaria
KK Women's & Children Hospital /ID# 206693
🇸🇬Singapore, Singapore
Changi General Hospital /ID# 205223
🇸🇬Singapore, Singapore
South Infirmary Victoria University Hospital /ID# 204265
🇮🇪Cork, Ireland
Centro Hospitalar de Leiria, EPE /ID# 209906
🇵🇹Leiria, Portugal
Chung Shan Medical University Hospital /ID# 205092
🇨🇳Taichung, Taiwan
National Taiwan University Hospital /ID# 204803
🇨🇳Taipei City, Taiwan
Klinik Donaustadt /ID# 206572
🇦🇹Vienna, Wien, Austria
National University Hospital /ID# 205224
🇸🇬Singapore, Singapore
Singapore General Hospital /ID# 205225
🇸🇬Singapore, Singapore
Hospital Vital Alvarez Buylla /ID# 205770
🇪🇸Mieres, Asturias, Spain
Taipei Medical University Shuang Ho Hospital /ID# 204804
🇨🇳New Taipei City, Taiwan
National Skin Centre /ID# 205222
🇸🇬Singapore, Central Singapore, Singapore
Poliklinika Vlatka Cavka d.o.o. /ID# 211126
🇭🇷Zagreb, Grad Zagreb, Croatia
Clinical Research Trials of Florida, Inc. /ID# 206840
🇺🇸Tampa, Florida, United States
David Fivenson, MD, PLC /ID# 206903
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895
🇺🇸Ann Arbor, Michigan, United States
Fordham Dermatology /ID# 218508
🇺🇸Bronx, New York, United States
Cyn3rgy Research /ID# 218064
🇺🇸Gresham, Oregon, United States
Timber Lane Allergy & Asthma Research, LLC /ID# 206897
🇺🇸South Burlington, Vermont, United States
Bellingham Asthma Allergy and Immunology Clinic /ID# 210357
🇺🇸Bellingham, Washington, United States
The Skin Centre /ID# 205922
🇦🇺Benowa, Queensland, Australia
The Education & Research Foundation, Inc. /ID# 206900
🇺🇸Lynchburg, Virginia, United States
Duplicate_Summit Medical Group /ID# 213863
🇺🇸Clifton, New Jersey, United States
University of New Mexico School of Medicine /ID# 206756
🇺🇸Albuquerque, New Mexico, United States
PMG Research of Wilmington LLC /ID# 205968
🇺🇸Wilmington, North Carolina, United States
EPIC Medical Research /ID# 206382
🇺🇸Murray, Utah, United States
Beacon Clinical Research, LLC /ID# 206894
🇺🇸Quincy, Massachusetts, United States
The Skin Hospital /ID# 217846
🇦🇺Westmead, New South Wales, Australia
Box Hill Hospital /ID# 206023
🇦🇺Box Hill, Victoria, Australia
Murdoch Children's Research Institute /ID# 205667
🇦🇺Parkville, Victoria, Australia