A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

• Status: Terminated
• Trial end date: 2020-08-06
• Target enrollment: 0
• Participant gender: All

Summary

This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks

• 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

• Chronic atopic dermatitis present for at least 1 year before Baseline

• Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.

• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable

• Candidate for systemic treatment

Exclusion Criteria:

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

• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.

• History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.

• Participation in prior ZPL389 studies