A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03568318
- Lead Sponsor
- AbbVie
- Brief Summary
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) 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, a blinded Long-term Extension (LTE) Period after Week 260 to Week 524, and a 30-day follow-up visit. Participants who meet eligibility criteria in the Main Study will be randomly assigned in a 1:1:1 ratio to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, in combination with topical corticosteroids.
Upon completion of enrollment of 810 participants in the Main Study, a supplemental study will continue to enroll adolescent participants (Adolescent Sub-study) until a total of 180 adolescent participants are enrolled in the overall study (Main Study + Adolescent Sub-study).
Approximately 1000 participants from M16-045 or M18-891 and approximately 500 participants from M16-047 will have the opportunity to enroll into the blinded Long-Term Extension (LTE) period (Week 260 - Week 524) after reaching Week 260 in their respective studies.
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 (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 \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]) and by geographic region (US/Puerto Rico/Canada and Other).
At Week 16 of both 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, and participants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose. For the Main Study, the re-randomization will be stratified by Eczema Area and Severity Index (EASI) 50 responder status (Yes/No), by geographic region (US/Puerto Rico/Canada, Japan, China, and Other) and by age (adolescent \[ages 12 to 17\] versus adult \[ages 18 to 75\]). 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).
Starting at Week 4, 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
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1500
- 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 Visit and subject meets Hanifin and Rajka criteria.
- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus numerical rating scale (NRS) ≥ 4.
- 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 or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis (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 + Topical Corticosteroids Placebo 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. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Upadacitinib 30 mg QD + Topical Corticosteroids Topical corticosteroids (TCS) Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Placebo / Upadacitinib + Topical Corticosteroids Topical corticosteroids (TCS) 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. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Upadacitinib 15 mg QD + Topical Corticosteroids Topical corticosteroids (TCS) Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Long-Term Extension Topical corticosteroids (TCS) Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524. Placebo / Upadacitinib + Topical Corticosteroids 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. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Upadacitinib 15 mg QD + Topical Corticosteroids Upadacitinib Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Upadacitinib 30 mg QD + Topical Corticosteroids Upadacitinib Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks. Participants will also receive concomitant topical corticosteroids following a step-down regimen through Week 52. Long-Term Extension Upadacitinib Participants who reach Week 260 in Studies M16-045, M18-891, and M16-047 will have the opportunity to roll over into the blinded LTE period of M16-047 to continue receiving the same daily dose of upadacitinib for up to Week 524.
- 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 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.
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 an EASI 75 Response at Week 4 Baseline and Week 4 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.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). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4 Baseline and Week 4 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 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 an EASI 90 Response at Week 4 Baseline and Week 4 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 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 from 0 \[none\], to 3 \[severe\]) for redness, thickness, scratching, and lichenification.
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.
The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only.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 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: 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 an EASI 100 Response at Week 16 Baseline and Week 16 EASI is used to measure the extent 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. and the severity score is calculated as the sum of the intensity scores (scored from 0 \[none\], to 3 \[severe\]) for redness, thickness, scratching, and lichenification.
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.
The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a secondary endpoint for participants in the Upadacitinib 30 mg + TCS group versus Placebo + TCS group only.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: 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 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 an EASI 90 Response at Week 4 Baseline and Week 4 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: 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.
Trial Locations
- Locations (193)
University of Pittsburgh MC /ID# 206057
🇺🇸Pittsburgh, Pennsylvania, United States
Kirk Barber Research, CA /ID# 200329
🇨🇦Calgary, Alberta, Canada
IMTR - Grand Hopital de Charleroi /ID# 202029
🇧🇪Loverval, Belgium
Dre Angelique Gagne-Henley M.D. inc. /ID# 200330
🇨🇦Saint-Jerome, Quebec, Canada
Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124
🇬🇷Thessaloniki, Greece
Allergo-Derm Bakos Kft. /ID# 205361
🇭🇺Szolnok, Hungary
University Hospital Waterford /ID# 201253
🇮🇪Waterford, Ireland
Azienda Ospedaliera Universitaria Federico II /ID# 200751
🇮🇹Napoli, Italy
Medical Corporation Matsuo Clinic /ID# 202312
🇯🇵Fukuoka-shi, Fukuoka, Japan
Research Toronto /ID# 205410
🇨🇦Toronto, Ontario, Canada
MediSearch Clinical Trials /ID# 201006
🇺🇸Saint Joseph, Missouri, United States
DermEdge Research Inc. /ID# 200337
🇨🇦Mississauga, Ontario, Canada
Toronto Research Centre /ID# 205411
🇨🇦Toronto, Ontario, Canada
Xiangya Hospital Central South University /ID# 207510
🇨🇳Changsha, China
Tufts Medical Center /ID# 200570
🇺🇸Boston, Massachusetts, United States
Deaconess Clinic Downtown /ID# 201001
🇺🇸Evansville, Indiana, United States
J. Schwartz, MD, PLLC /ID# 202122
🇺🇸Troy, New York, United States
St James Hospital /ID# 201118
🇮🇪Dublin 8, Dublin, Ireland
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256
🇩🇪Kiel, Schleswig-Holstein, Germany
Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556
🇺🇸Skokie, Illinois, United States
University of Arizona /ID# 201059
🇺🇸Tucson, Arizona, United States
Mosaic Dermatology /ID# 200553
🇺🇸Beverly Hills, California, United States
Stanford University /ID# 200597
🇺🇸Stanford, California, United States
Indiana University /ID# 200515
🇺🇸Indianapolis, Indiana, United States
DuPage Medical Group /ID# 202065
🇺🇸Wheaton, Illinois, United States
Therapeutics Clinical Research /ID# 200593
🇺🇸San Diego, California, United States
University of California Irvine /ID# 200902
🇺🇸Irvine, California, United States
Bakersfield Derma & Skin Cance /ID# 200892
🇺🇸Bakersfield, California, United States
Tory P Sullivan, MD PA /ID# 201174
🇺🇸North Miami Beach, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 201646
🇺🇸Chicago, Illinois, United States
Epiphany Dermatology of Kansas LLC /ID# 203026
🇺🇸Overland Park, Kansas, United States
Bexley Dermatology Research /ID# 200899
🇺🇸Bexley, Ohio, United States
Eastern Virginia Med School /ID# 200994
🇺🇸Norfolk, Virginia, United States
Westmead Hospital /ID# 205682
🇦🇺Westmead, New South Wales, Australia
The Ohio State University /ID# 200542
🇺🇸Columbus, Ohio, United States
Arlington Research Center, Inc /ID# 200559
🇺🇸Arlington, Texas, United States
Dermatology Associates of Seattle /ID# 200717
🇺🇸Seattle, Washington, United States
Vital Prospects Clinical Research Institute, PC /ID# 200901
🇺🇸Tulsa, Oklahoma, United States
Rhode Island Hospital /ID# 200566
🇺🇸Providence, Rhode Island, United States
Royal North Shore Hospital /ID# 204639
🇦🇺St Leonards, New South Wales, Australia
Juva Skin and Laser Center /ID# 200997
🇺🇸New York, New York, United States
AAPRI Clinical Research /ID# 221134
🇺🇸Warwick, Rhode Island, United States
UCL Saint-Luc /ID# 202028
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Vseobecna fakultni nemocnice v Praze /ID# 202045
🇨🇿Praha, Czechia
Angela Montgomery Medicine Professional Corporation /ID# 212653
🇨🇦Ottawa, Ontario, Canada
Fakultni nemocnice Plzen /ID# 202044
🇨🇿Plzen, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 205780
🇫🇷Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 206128
🇫🇷Marseille CEDEX 05, Bouches-du-Rhone, France
Hopital Saint-Andre /ID# 206129
🇫🇷Bordeaux, France
Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248
🇨🇿Prague, Czechia
Universitaetsklinikum Muenster /ID# 202094
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Sanatorium profesora Arenbergera /ID# 202082
🇨🇿Praha, Czechia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744
🇮🇹Milan, Italy
Chukyo Hospital /ID# 202311
🇯🇵Nagoya-shi, Aichi, Japan
Academisch Medisch Centrum /ID# 202193
🇳🇱Amsterdam, Netherlands
CHRU Tours - Hopital Gatien de Clocheville /ID# 218209
🇫🇷Tours, Centre-Val De Loire, France
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194
🇩🇪Mainz, Germany
The Chaim Sheba Medical Center /ID# 201611
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 201608
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Medical Corporation Kojinkai Sapporo Skin Clinic /ID#258665
🇯🇵Sapporo-shi, Hokkaido, Japan
Hospital Universitario de la Princesa /ID# 201517
🇪🇸Madrid, Spain
Hospital General Universitario Alicante /ID# 200873
🇪🇸Alicante, Spain
Clinical Trials NZ /ID# 205336
🇳🇿Hamilton, New Zealand
Hospital Santa Creu i Sant Pau /ID# 201325
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 201135
🇪🇸Madrid, Spain
Hospital Universitario La Paz /ID# 205438
🇪🇸Madrid, Spain
Skane University Hospital Lund /ID# 201244
🇸🇪Lund, Skane Lan, Sweden
Sodersjukhuset /ID# 201242
🇸🇪Stockholm, Sweden
Karolinska University Hospital /ID# 201243
🇸🇪Stockholm, Sweden
Barts Health NHS Trust /ID# 201044
🇬🇧London, London, City Of, United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 204642
🇬🇧London, London, City Of, United Kingdom
Sahlgrenska University Hospital /ID# 201274
🇸🇪Gothenburg, Vastra Gotalands Lan, Sweden
Guy's and St Thomas' NHS Foundation Trust /ID# 201193
🇬🇧London, London, City Of, United Kingdom
Total Skin and Beauty Derm Ctr /ID# 200548
🇺🇸Birmingham, Alabama, United States
Clinical Research Center AL /ID# 201865
🇺🇸Birmingham, Alabama, United States
Alliance Dermatology and MOHs Center, PC /ID#200540
🇺🇸Phoenix, Arizona, United States
ACCEL Research Sites /ID# 213364
🇺🇸Birmingham, Alabama, United States
Progressive Clinical Research /ID# 201582
🇺🇸San Antonio, Texas, United States
Oregon Dermatology and Research Center /ID# 200601
🇺🇸Portland, Oregon, United States
Advanced Clinical Research - Woseth Dermatology /ID# 213745
🇺🇸Salt Lake City, Utah, United States
Skin Care Research, LLC /ID# 200812
🇺🇸Boca Raton, Florida, United States
Clearlyderm Dermatology /ID# 207709
🇺🇸Boca Raton, Florida, United States
Advanced Dermatology and Skin Care Centre /ID# 213550
🇺🇸Mobile, Alabama, United States
Park Avenue Dermatology, PA /ID# 201012
🇺🇸Orange Park, Florida, United States
Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628
🇺🇸Boise, Idaho, United States
Center for Clinical Studies /ID# 200582
🇺🇸Houston, Texas, United States
St George Dermatology & Skin Cancer Centre /ID# 204788
🇦🇺Kogarah, New South Wales, Australia
Karma Clinical Trials /ID# 200339
🇨🇦St. John's, Newfoundland and Labrador, Canada
The Centre for Clinical Trials /ID# 205404
🇨🇦Oakville, Ontario, Canada
SKIN Centre for Dermatology /ID# 200331
🇨🇦Peterborough, Ontario, Canada
The Center For Dermatology /ID# 205409
🇨🇦Richmond Hill, Ontario, Canada
CHU Sainte-Justine /ID# 206013
🇨🇦Montreal, Quebec, Canada
Chinese PLA General Hospital /ID# 206786
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132
🇨🇳Hangzhou, Zhejiang, China
Huashan Hospital of Fudan University /ID# 207437
🇨🇳Shanghai, China
CMS3 Company for Medical Study /ID# 205195
🇩🇪Selters, Rheinland-Pfalz, Germany
Universitaetsklinikum Bonn /ID# 202092
🇩🇪Bonn, Germany
Polyclinique Courlancy /ID# 201537
🇫🇷Reims, France
Medizinische Hochschule Hannover /ID# 202098
🇩🇪Hannover, Germany
Children's Hosp P. A. Kyriakou /ID# 217573
🇬🇷Athens, Attiki, Greece
Universitaetsklinik Heidelberg /ID# 202097
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Frankfurt /ID# 202095
🇩🇪Frankfurt am Main, Hessen, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093
🇩🇪Munich, Germany
TFS Trial Form Support GmbH /ID# 202096
🇩🇪Hamburg, Germany
401 GSNA - 401 Army General Hospital /ID# 211963
🇬🇷Athens, Attiki, Greece
Papageorgiou General Hospital Thessaloniki /ID# 202392
🇬🇷Stavroupoli (Thessalonikis), Thessaloniki, Greece
Prince of Wales Hospital /ID# 205152
🇭🇰Hong Kong, Hong Kong
General Hospital Andreas Syggros /ID# 201123
🇬🇷Athens, Attiki, Greece
Queen Mary Hospital /ID# 205146
🇭🇰Hong Kong, Hong Kong
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866
🇭🇺Debrecen, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 201765
🇭🇺Debrecen, Hajdu-Bihar, Hungary
South Infirmary Victoria University Hospital /ID# 201079
🇮🇪Cork, Ireland
Rabin Medical Center /ID# 201959
🇮🇱Petakh Tikva, Israel
HaEmek Medical Center /ID# 201958
🇮🇱Afula, Israel
Universitair Medisch Centrum Utrecht /ID# 202194
🇳🇱Utrecht, Netherlands
Universitetssykehuset N-Norge, Tromso /ID# 201270
🇳🇴Tromso, Troms, Norway
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240
🇸🇰Nove Zamky, Slovakia
Hospital Universitario de Puerto Real /ID# 200875
🇪🇸Puerto Real, Cadiz, Spain
Leeds Teaching Hospitals NHS Trust /ID# 201106
🇬🇧Leeds, United Kingdom
Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822
🇺🇸Aurora, Colorado, United States
Arizona Research Center, Inc. /ID# 200546
🇺🇸Phoenix, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 201257
🇺🇸Scottsdale, Arizona, United States
Beth Israel Deaconess Medical Center /ID# 200545
🇺🇸Boston, Massachusetts, United States
Skin Specialists, PC /ID# 200573
🇺🇸Omaha, Nebraska, United States
Clin Res Inst of Michigan, LLC /ID# 208020
🇺🇸Chesterfield, Michigan, United States
Dartmouth-Hitchcock Medical Center /ID# 200918
🇺🇸Lebanon, New Hampshire, United States
Clinical Research of West Florida, Inc /ID# 203643
🇺🇸Clearwater, Florida, United States
Dermatology Physicians of Connecticut /ID# 201004
🇺🇸Shelton, Connecticut, United States
Florida Academic Centers Research and Education /ID# 200544
🇺🇸Coral Gables, Florida, United States
Psoriasis Treatment Center of Central New Jersey /ID# 200714
🇺🇸East Windsor, New Jersey, United States
Rivergate Dermatology & Skin Care Center /ID# 201698
🇺🇸Goodlettsville, Tennessee, United States
Stones River Dermatology /ID# 204962
🇺🇸Murfreesboro, Tennessee, United States
Ordensklinikum Linz GmbH Elisabethinen /ID# 209567
🇦🇹Linz, Oberoesterreich, Austria
Kepler Universitaetsklinikum GmbH /ID# 201075
🇦🇹Linz, Oberoesterreich, Austria
Medizinische Universitaet Innsbruck /ID# 210897
🇦🇹Innsbruck, Tirol, Austria
Lynderm Research Inc. /ID# 200338
🇨🇦Markham, Ontario, Canada
Medizinische Universitaet Wien /ID# 201080
🇦🇹Vienna, Wien, Austria
UZ Brussel /ID# 203557
🇧🇪Jette, Bruxelles-Capitale, Belgium
UZ Gent /ID# 202030
🇧🇪Gent, Oost-Vlaanderen, Belgium
Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403
🇨🇦Québec, Quebec, Canada
Eastern Canada Cutaneous Resea /ID# 200335
🇨🇦Halifax, Nova Scotia, Canada
University of Wisconsin - Madison /ID# 204933
🇺🇸Madison, Wisconsin, United States
Veracity Clinical Research /ID# 204793
🇦🇺Woolloongabba, Queensland, Australia
Dermatology Research Institute Inc. /ID# 200341
🇨🇦Calgary, Alberta, Canada
Alberta DermaSurgery Centre /ID# 205674
🇨🇦Edmonton, Alberta, Canada
XLR8 Medical Research /ID# 205405
🇨🇦Windsor, Ontario, Canada
Beijing Friendship Hospital /ID# 207434
🇨🇳Beijing, China
The First Hospital of China Medical University /ID# 209840
🇨🇳Shenyang, Liaoning, China
University General Hospital Attikon /ID# 201126
🇬🇷Athens, Attiki, Greece
Oroshazi Korhaz /ID# 203525
🇭🇺Oroshaza, Bekes, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144
🇭🇺Szeged, Csongrad, Hungary
Soroka University Medical Center /ID# 206652
🇮🇱Be'er Sheva, HaDarom, Israel
Istituto Clinico Humanitas /ID# 200739
🇮🇹Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690
🇮🇹Ancona, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742
🇮🇹Catania, Italy
Hiramoto skin clinic /ID# 204048
🇯🇵Amagasaki-shi, Hyogo, Japan
Queens Square Medical Center dermatology allergology /ID# 203850
🇯🇵Yokohama-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID#258604
🇯🇵Kyoto-shi, Kyoto, Japan
Kyoto University Hospital /ID# 201654
🇯🇵Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 206322
🇯🇵Sendai-shi, Miyagi, Japan
Jichi Medical University Hospital /ID# 201913
🇯🇵Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital /ID# 202888
🇯🇵Bunkyo-ku, Tokyo, Japan
Hiroshima University Hospital /ID# 201914
🇯🇵Hiroshima-shi, Hiroshima, Japan
Erasmus Medisch Centrum /ID# 202196
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Haukeland University Hospital /ID# 201152
🇳🇴Bergen, Hordaland, Norway
Rikshospitalet OUS HF /ID# 201271
🇳🇴Oslo, Norway
National Hospital Organization Sagamihara National Hospital /ID# 201658
🇯🇵Sagamihara-shi, Kanagawa, Japan
Osaka Habikino Medical Center /ID# 204243
🇯🇵Habikino-shi, Osaka, Japan
Tokai University Hachioji Hospital /ID# 201711
🇯🇵Hachioji-shi, Tokyo, Japan
Maruyama Dermatology Clinic /ID# 202350
🇯🇵Koto-ku, Tokyo, Japan
Universitair Medisch Centrum Groningen /ID# 202195
🇳🇱Groningen, Netherlands
Universitetssykehuset N-Norge, Harstad /ID# 201269
🇳🇴Harstad, Troms, Norway
Dr. Samuel Sanchez PSC /ID# 202002
🇵🇷Caguas, Puerto Rico
Clinical Research Puerto Rico /ID# 203644
🇵🇷San Juan, Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 202003
🇵🇷San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372
🇸🇰Banska Bystrica, Slovakia
Univerzitna nemocnica Martin /ID# 203851
🇸🇰Martin, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373
🇸🇰Presov, Slovakia
Oxford University Hospitals NHS Foundation Trust /ID# 202052
🇬🇧Oxford, Oxfordshire, United Kingdom
Yamate Dermatological Clinic /ID# 202130
🇯🇵Shinjuku-ku, Tokyo, Japan
NHS Tayside /ID# 202081
🇬🇧Dundee, Scotland, United Kingdom
NHS Greater Glasgow and Clyde /ID# 201374
🇬🇧Glasgow, Scotland, United Kingdom
Precision Clinical Research /ID# 208734
🇺🇸Sunrise, Florida, United States
Michigan Center for Research Company /ID# 200560
🇺🇸Clarkston, Michigan, United States
Fremantle Dermatology /ID# 205306
🇦🇺Fremantle, Western Australia, Australia
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728
🇨🇳Guangzhou, Guangdong, China
Colorado Center for Dermatology, PLLC /ID# 203626
🇺🇸Centennial, Colorado, United States
Duplicate_Western States Clinical Research, Inc. /ID# 201702
🇺🇸Wheat Ridge, Colorado, United States
ORA, Inc. /ID# 202824
🇺🇸Andover, Massachusetts, United States
Center for Clinical Studies - Webster TX /ID# 203186
🇺🇸Webster, Texas, United States
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014
🇮🇹Rome, Lazio, Italy
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669
🇨🇳Wuhan, Hubei, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442
🇨🇳Hangzhou, Zhejiang, China