A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03661138
- Lead Sponsor
- AbbVie
- Brief Summary
The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus.
- Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.
- Able to tolerate topical corticosteroids for atopic dermatitis lesions.
- 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.
- Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Topical Corticosteroids (TCS) Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS). Arm C Placebo for upadacitinib Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS. Arm A Topical Corticosteroids (TCS) Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS). Arm D Placebo for upadacitinib Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS. Arm D Topical Corticosteroids (TCS) Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS. Arm C Topical Corticosteroids (TCS) Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS. Arm A Upadacitinib Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS). Arm B Upadacitinib Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS). Arm C Upadacitinib Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS. Arm D Upadacitinib Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
- Primary Outcome Measures
Name Time Method Number of participants experiencing adverse events Up to 141 Weeks Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Ichinomiya Municipal Hospital /ID# 205942
🇯🇵Ichinomiya-shi, Aichi, Japan
Nagoya City University Hospital /ID# 207566
🇯🇵Nagoya shi, Aichi, Japan
Central Clinic /ID# 206558
🇯🇵Nagoya-shi, Aichi, Japan
Yasumoto Dermatology Clinic /ID# 206480
🇯🇵Chikushino-shi, Fukuoka, Japan
Kiryu Dermatology Clinic /ID# 206044
🇯🇵Fukuoka-shi, Fukuoka, Japan
Medical Corporation Matsuo Clinic /ID# 207323
🇯🇵Fukuoka-shi, Fukuoka, Japan
Matsuda Tomoko Dermatological Clinic /ID# 206288
🇯🇵Fukuoka-shi, Fukuoka, Japan
Higuchi Dermatology Urology Clinic /ID# 206287
🇯🇵Kasuga-shi, Fukuoka, Japan
Central Japan International Medical Center /ID# 205684
🇯🇵Minokamo-shi, Gifu, Japan
Kiryu Kosei General Hospital /ID# 206155
🇯🇵Kiryu-shi, Gunma, Japan
Scroll for more (33 remaining)Ichinomiya Municipal Hospital /ID# 205942🇯🇵Ichinomiya-shi, Aichi, Japan