NCT03607422
Brief summary
The objective of this study is to assess the efficacy and safety of an active drug for the treatment of adolescent and adult participants with moderate to severe AD who are candidates for systemic therapy.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 12 Years to 75 Years.
Inclusion Criteria:
- Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline and subject meets Hanifin and Rajka criteria
- Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16,
validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA)
affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating
scale (NRS) score ≥ 4.
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Documented history (within 6 months prior to Baseline) of inadequate response to
topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
systemic treatment for AD or for whom topical treatments are otherwise medically
inadvisable due to side effects or safety risks
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current AD treatments prior to the study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would
interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the
study
