drugset / Trial / NCT03948334

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

NCT03948334

Phase 2 Terminated 123 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject ADRIFORANT Small molecule 30 mg Oral
Subject ADRIFORANT Small molecule 50 mg Oral

Indications