Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03569293
- 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 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 in the overall study (main study + adolescent sub-study).
Randomization for 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, Japan, China, 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, China \[Mainland\], Japan, 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 between ≥ 12 and < 18 years of age
-
Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
-
Active moderate to severe AD defined by:
- Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
- Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
- ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
-
Candidate for systemic therapy or have recently required systemic therapy for AD
-
Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
-
Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis 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;
* 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 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). 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: 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). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.
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 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 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 ≥ 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.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 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). 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 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). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
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 Baseline and 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.
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 ≥ 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).
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 ≥ 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.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.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 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 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 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;
* 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.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.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 ≥ 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 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 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 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 ≥ 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 ≥ 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: 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 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). 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 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: 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.
Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16 Baseline and 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 DLQI Score of 0 or 1 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. 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.
Trial Locations
- Locations (180)
Massachusetts General Hospital /ID# 200474
🇺🇸Boston, Massachusetts, United States
Dawes Fretzin, LLC /ID# 200366
🇺🇸Indianapolis, Indiana, United States
Erciyes University Medical Fac /ID# 204098
🇹🇷Melikgazi, Kayseri, Turkey
Hôpitaux Universitaires Genève /ID# 201600
🇨🇭Genève, Geneve, Switzerland
Inselspital, Universitätsspital Bern /ID# 201598
🇨🇭Bern, Switzerland
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608
🇨🇳Hangzhou, Zhejiang, China
Florida International Rsrch cr /ID# 218507
🇺🇸Miami, Florida, United States
Allergy & Asthma Associates of Southern California /ID# 200733
🇺🇸Mission Viejo, California, United States
UC Davis /ID# 203622
🇺🇸Sacramento, California, United States
Clinisalud del sur /ID# 218100
🇨🇴Medellin, Antioquia, Colombia
Ctr Int de Reum del Caribe SAS /ID# 201620
🇨🇴Barranquilla, Atlantico, Colombia
Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905
🇨🇴Monteria, Cordoba, Colombia
Menter Dermatology Res Inst /ID# 200390
🇺🇸Dallas, Texas, United States
Stanford University /ID# 200440
🇺🇸Stanford, California, United States
GSI Clinical Research, LLC /ID# 200849
🇺🇸Margate, Florida, United States
Advanced Dermatology of the Midlands /ID# 201689
🇺🇸Omaha, Nebraska, United States
Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313
🇨🇦Hamilton, Ontario, Canada
Clin Res Inst of Michigan, LLC /ID# 208019
🇺🇸Chesterfield, Michigan, United States
K. Papp Clinical Research /ID# 200317
🇨🇦Waterloo, Ontario, Canada
Arlington Research Center, Inc /ID# 200391
🇺🇸Arlington, Texas, United States
Orion Clinical Research /ID# 204703
🇺🇸Austin, Texas, United States
Dermdox Dermatology Centers, PC /ID# 213782
🇺🇸Hazleton, Pennsylvania, United States
Peking University People's Hospital /ID# 202549
🇨🇳Beijing, Beijing, China
Modern Research Associates, PL /ID# 200705
🇺🇸Dallas, Texas, United States
Oregon Medical Res Center PC /ID# 200428
🇺🇸Portland, Oregon, United States
Tory P Sullivan, MD PA /ID# 200671
🇺🇸North Miami Beach, Florida, United States
UMHAT Professor Stoyan Kirkovich /ID# 201522
🇧🇬Stara Zagora, Bulgaria
Christie Clinic, LLC /ID# 200427
🇺🇸Champaign, Illinois, United States
Clinical Center University of Sarajevo /ID# 202668
🇧🇦Sarajevo, Bosnia and Herzegovina
Dr. Chih-ho Hong Medical Inc. /ID# 200311
🇨🇦Surrey, British Columbia, Canada
Velocity clinical research /ID# 202653
🇺🇸Cleveland, Ohio, United States
Montefiore Medical Center /ID# 200456
🇺🇸Bronx, New York, United States
UMHAT Alexandrovska EAD /ID# 201519
🇧🇬Sofiya, Sofia, Bulgaria
Dr. Irina Turchin PC Inc. /ID# 200322
🇨🇦Fredericton, New Brunswick, Canada
Icahn School of Medicine at Mount Sinai /ID# 200370
🇺🇸New York, New York, United States
Cleaver Dermatology /ID# 202825
🇺🇸Kirksville, Missouri, United States
Framingham Centro Medico /ID# 202688
🇦🇷La Plata, Buenos Aires, Argentina
North Eastern Health Specialists /ID# 205802
🇦🇺Hectorville, South Australia, Australia
Clinical Center University of Sarajevo /ID# 202669
🇧🇦Sarajevo, Bosnia and Herzegovina
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598
🇨🇳Wuhan, China
Dr. David Gratton Dermat Inc. /ID# 200309
🇨🇦Montreal, Quebec, Canada
UMHAT Dr Georgi Stranski EAD /ID# 201521
🇧🇬Pleven, Bulgaria
Skin Health Institute Inc /ID# 204791
🇦🇺Carlton, Victoria, Australia
Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962
🇺🇦Zaporizhzhya, Zaporizka Oblast, Ukraine
Klinicki bolnicki centar Split /ID# 201527
🇭🇷Split, Splitsko-dalmatinska Zupanija, Croatia
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554
🇨🇳Shanghai, Shanghai, China
Fondazione PTV Policlinico Tor Vergata /ID# 201136
🇮🇹Rome, Roma, Italy
Barts Health NHS Trust /ID# 201043
🇬🇧London, London, City Of, United Kingdom
Beijing Friendship Hospital /ID# 202601
🇨🇳Beijing, China
Peking University Third Hospital /ID# 202612
🇨🇳Beijing, Beijing, China
Hôpital Charles-Nicolle /ID# 201525
🇫🇷Rouen, France
Clinical Dermatovenerology Dispensary /ID# 203439
🇷🇺Krasnodar, Krasnodarskiy Kray, Russian Federation
Le Bateau BLanc /ID# 206833
🇫🇷Martigues, France
CHU Toulouse - Hopital Larrey /ID# 201528
🇫🇷Toulouse, France
North Estonia Medical Centre /ID# 200951
🇪🇪Mustamäe Linnaosa, Harjumaa, Estonia
Tartu University Hospital /ID# 200847
🇪🇪Tartu Linn, Tartumaa, Estonia
Terveystalo Tampere /ID# 201117
🇫🇮Tampere, Finland
Duplicate_Klinicki bolnicki centar Osijek /ID# 201523
🇭🇷Osijek, Osjecko-baranjska Zupanija, Croatia
Huashan Hospital of Fudan University /ID# 205760
🇨🇳Shanghai, China
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548
🇨🇳Guangzhou, Guangdong, China
The First Hospital of China Medical University /ID# 202615
🇨🇳Shenyang, Liaoning, China
Universitaetsklinikum Muenster /ID# 202085
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087
🇩🇪Munich, Bayern, Germany
Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043
🇨🇴Rionegro, Antioquia, Colombia
Mehiläinen Neo /ID# 201116
🇫🇮Turku, Varsinais-Suomi, Finland
Spitalul Clinic Colentina /ID# 205860
🇷🇴Bucuresti, Romania
Klinicki bolnicki centar Rijeka /ID# 217423
🇭🇷Rijeka, Primorsko-goranska Zupanija, Croatia
Gazi Universitesi Tip Fakultes /ID# 204176
🇹🇷Yenimahalle, Turkey
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891
🇯🇵Fukuoka-shi, Fukuoka, Japan
CHU de Nantes, Hotel Dieu -HME /ID# 206377
🇫🇷Nantes, Pays-de-la-Loire, France
HCL - Hôpital Lyon Sud /ID# 201529
🇫🇷Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
Universitaetsklinikum Bonn /ID# 202086
🇩🇪Bonn, Germany
Confido Private Medical Clinic /ID# 200846
🇪🇪Tallinn, Harjumaa, Estonia
Kuopio University Hospital /ID# 202449
🇫🇮Kuopio, Finland
Centre Hospitalier du Mans /ID# 205991
🇫🇷Le Mans CEDEX 9, Sarthe, France
Klinicki bolnicki centar Zagreb /ID# 201879
🇭🇷Zagreb, Grad Zagreb, Croatia
Klinika za dječje bolesti Zagreb /ID# 203151
🇭🇷Zagreb, Grad Zagreb, Croatia
Universitaetsklinikum Frankfurt /ID# 202089
🇩🇪Frankfurt am Main, Hessen, Germany
AP-HP - Hopital Necker /ID# 218364
🇫🇷Paris, France
Ponce Medical School Foundation /ID# 201821
🇵🇷Ponce, Puerto Rico
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695
🇮🇹Pisa, Italy
Guy's and St Thomas' NHS Foundation Trust /ID# 201192
🇬🇧London, London, City Of, United Kingdom
Hopital Saint Vincent de Paul /ID# 218253
🇫🇷Lille Cedex, France
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192
🇩🇪Mainz, Germany
National Medical Research Center for Children's Health /ID# 203440
🇷🇺Moscow, Russian Federation
CHUV, Centre hospitalier universitaire vaudois /ID# 200910
🇨🇭Lausanne, Vaud, Switzerland
Fukuoka University Hospital /ID# 201309
🇯🇵Fukuoka-shi, Fukuoka, Japan
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100
🇹🇷Istanbul, Turkey
TFS Trial Form Support GmbH /ID# 202083
🇩🇪Hamburg, Germany
Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862
🇷🇴Cluj Napoca, Romania
CMS3 Company for Medical Study /ID# 205193
🇩🇪Selters, Rheinland-Pfalz, Germany
Clinical Trials NZ /ID# 205335
🇳🇿Hamilton, New Zealand
Hospital Raja Permaisuri Bainun /ID# 204375
🇲🇾Ipoh, Perak, Malaysia
Ogaki Municipal Hospital /ID# 203463
🇯🇵Ogaki-shi, Gifu, Japan
Takagi Dermatology Clinic /ID# 201238
🇯🇵Obihiro-shi, Hokkaido, Japan
Queen Elizabeth Hospital /ID# 204379
🇲🇾Division Pantai Barat Utara, Sabah, Malaysia
Hospital Selayang /ID# 204378
🇲🇾Batu Caves, Selangor, Malaysia
Cruz-Santana, Carolina, PR /ID# 201096
🇵🇷Carolina, Puerto Rico
Clinical Research Puerto Rico /ID# 203309
🇵🇷San Juan, Puerto Rico
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595
🇷🇺Saratov, Saratovskaya Oblast, Russian Federation
Medizinische Hochschule Hannover /ID# 202091
🇩🇪Hannover, Germany
Universitätsspital Basel /ID# 201599
🇨🇭Basel, Basel-Stadt, Switzerland
West Middlesex University Hospital /ID# 202273
🇬🇧Isleworth, London, City Of, United Kingdom
Hacettepe University Faculty of Medicine /ID# 204099
🇹🇷Ankara, Turkey
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Aichi Medical University Hospital /ID# 202833
🇯🇵Nagakute-shi, Aichi, Japan
Gifu University Hospital /ID# 201760
🇯🇵Gifu-shi, Gifu, Japan
ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504
🇺🇦Rivne, Ukraine
Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971
🇬🇧London, United Kingdom
Alliance Dermatology and MOHs /ID# 200375
🇺🇸Phoenix, Arizona, United States
Synergy Dermatology /ID# 200842
🇺🇸San Francisco, California, United States
Henry Ford Medical Center /ID# 204191
🇺🇸Detroit, Michigan, United States
Lynn Health Science Institute (LHSI) /ID# 212676
🇺🇸Oklahoma City, Oklahoma, United States
Bispebjerg and Frederiksberg Hospital /ID# 200979
🇩🇰Copenhagen NV, Hovedstaden, Denmark
Herlev and Gentofte Hospital /ID# 200736
🇩🇰Hellerup, Hovedstaden, Denmark
Aarhus University Hospital /ID# 200737
🇩🇰Aarhus N, Midtjylland, Denmark
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692
🇮🇹Ancona, Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 200750
🇮🇹Napoli, Italy
Northern Care Alliance NHS Group /ID# 201194
🇬🇧Salford, United Kingdom
Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239
🇯🇵Sapporo-shi, Hokkaido, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 201876
🇯🇵Kyoto-shi, Kyoto, Japan
Kume Clinic /ID# 201912
🇯🇵Sakai-shi, Osaka, Japan
University of Yamanashi Hospital /ID# 204174
🇯🇵Chuo-shi, Yamanashi, Japan
Kirk Barber Research, CA /ID# 200324
🇨🇦Calgary, Alberta, Canada
Dermatology Research Institute Inc. /ID# 200318
🇨🇦Calgary, Alberta, Canada
Lynderm Research Inc. /ID# 200315
🇨🇦Markham, Ontario, Canada
Wiseman Dermatology Research /ID# 200323
🇨🇦Winnipeg, Manitoba, Canada
Innovaderm Research Inc. /ID# 200320
🇨🇦Montréal, Quebec, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 200326
🇨🇦Saint-Jerome, Quebec, Canada
Ural Research Institute of dermatovenerology and immunopathology /ID# 201593
🇷🇺Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Instituto de Neumonología y Dermatología /ID# 203444
🇦🇷Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Psoriahue Med Interdisciplinar /ID# 202451
🇦🇷Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Bakersfield Derma & Skin Cance /ID# 200433
🇺🇸Bakersfield, California, United States
Clear Dermatology & Aesthetics Center /ID# 201256
🇺🇸Scottsdale, Arizona, United States
First OC Dermatology /ID# 201910
🇺🇸Fountain Valley, California, United States
California Allergy and Asthma Medical Group /ID# 200727
🇺🇸Los Angeles, California, United States
Dermatology Clinical Trials /ID# 205876
🇺🇸Newport Beach, California, United States
San Luis Derm and Laser Clinic /ID# 200372
🇺🇸San Luis Obispo, California, United States
Care Access Research - Walnut Creek /ID# 200940
🇺🇸Walnut Creek, California, United States
Duplicate_George Washington Univ Med /ID# 200364
🇺🇸Washington, District of Columbia, United States
Skin Care Research, LLC /ID# 200811
🇺🇸Boca Raton, Florida, United States
Foxhall Research Center /ID# 213682
🇺🇸Washington, District of Columbia, United States
Olympian Clinical Research /ID# 202914
🇺🇸Clearwater, Florida, United States
Clearlyderm Dermatology /ID# 208371
🇺🇸Boca Raton, Florida, United States
Multi-Speciality Research Associates /ID# 213254
🇺🇸Lake City, Florida, United States
Precision Clinical Research /ID# 209002
🇺🇸Sunrise, Florida, United States
Integrated Clinical Research LLC /ID# 200900
🇺🇸West Palm Beach, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 201644
🇺🇸Chicago, Illinois, United States
Clinical Trials Management, LLC - Covington /ID# 212658
🇺🇸Covington, Louisiana, United States
The South Bend Clinic Center /ID# 200371
🇺🇸South Bend, Indiana, United States
Northeast Dermatology /ID# 201338
🇺🇸Beverly, Massachusetts, United States
Integrated Dermatology of Massachusetts, LLC /ID# 209468
🇺🇸Quincy, Massachusetts, United States
Clinical Research Consortium /ID# 200734
🇺🇸Las Vegas, Nevada, United States
AllCutis Research Inc /ID# 200981
🇺🇸Portsmouth, New Hampshire, United States
Forest Hills Dermatology Group /ID# 209244
🇺🇸Kew Gardens, New York, United States
Clinical Partners, LLC /ID# 200460
🇺🇸Johnston, Rhode Island, United States
Coastal Clinical Research Center of the Carolinas /ID# 200402
🇺🇸Charleston, South Carolina, United States
Oregon Health and Science University /ID# 200992
🇺🇸Portland, Oregon, United States
Newton Clinical Research /ID# 204169
🇺🇸Oklahoma City, Oklahoma, United States
Dermatology Physicians of Connecticut /ID# 200928
🇺🇸Shelton, Connecticut, United States
Clinical Trials Management, LLC - Metairie /ID# 212659
🇺🇸Metairie, Louisiana, United States
Leavitt Medical Associates of Florida /ID# 200880
🇺🇸Ormond Beach, Florida, United States
J. Schwartz, MD, PLLC /ID# 202121
🇺🇸Troy, New York, United States
Center for Clinical Studies - Webster TX /ID# 203185
🇺🇸Webster, Texas, United States
Dermatology Specialists of Spokane /ID# 202068
🇺🇸Spokane, Washington, United States
Woden Dermatology /ID# 205799
🇦🇺Phillip, Australian Capital Territory, Australia
Holdsworth House Medical Practice /ID# 211236
🇦🇺Darlinghurst, New South Wales, Australia
Dr. Wei Jing Loo Medicine Prof /ID# 206051
🇨🇦London, Ontario, Canada
Fremantle Dermatology /ID# 205305
🇦🇺Fremantle, Western Australia, Australia
University Clinical Centre of the Republic of Srpska /ID# 202666
🇧🇦Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 202667
🇧🇦Banja Luka, Republika Srpska, Bosnia and Herzegovina
Enverus Medical Research /ID# 200307
🇨🇦Surrey, British Columbia, Canada
Karma Clinical Trials /ID# 200316
🇨🇦St. John's, Newfoundland and Labrador, Canada
Dermatology Ottawa Research Centre /ID# 200319
🇨🇦Ottawa, Ontario, Canada
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597
🇨🇳Guangzhou, Guangdong, China
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255
🇩🇪Kiel, Schleswig-Holstein, Germany
NTT Medical Center Tokyo /ID# 201759
🇯🇵Shinagawa-ku, Tokyo, Japan
CHUV, Centre hospitalier universitaire vaudois /ID# 206505
🇨🇭Lausanne, Vaud, Switzerland