A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients

• Status: Terminated
• Trial end date: 2020-08-25
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Subjects must give a written, signed and dated informed consent

• Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.

Exclusion Criteria:

• Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).

• Treatment discontinued subject from CZPL389A2203 study.

• Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.