drugset / Trial / NCT03948334
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI).
Timeline
- Start
- 2019-04-04
- Primary completion
- 2020-07-23
- Completion
- 2020-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADRIFORANT | Small molecule | 30 mg | Oral |
| Subject | ADRIFORANT | Small molecule | 50 mg | Oral |