Actively Recruiting
Phase II Study to Test Safety and Effectiveness of GHZ339 and Other Treatments in Adults With Moderate to Severe Atopic Dermatitis
Led by Novartis Pharmaceuticals · Updated on 2025-12-22
224
Participants Needed
99
Research Sites
3 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating multiple investigational compounds in adults with moderate to severe atopic dermatitis AD to assess their effectiveness and safety. This multicenter, randomized, double-blind, placebo-controlled Phase II platform study focuses on evaluating these treatments, with the initial compound being GHZ339. The study aims to better understand potential new options for managing moderate to severe AD. Participants will be randomly assigned to receive one of several doses of GHZ339 or a matching placebo during the first treatment period. Those receiving GHZ339 at specific doses in the first period will continue with the same or adjusted dose in the second treatment period, while those initially on placebo will receive GHZ339 at dose A in the second period. This design allows comparison of different doses and placebo effects across two treatment periods. During the study, participants will be monitored for changes in their eczema severity using the Eczema Area and Severity Index EASI score and other assessments like the Investigator Global Assessment IGA at baseline and Week 16. The study includes regular evaluations to track safety and treatment impact. Total participation duration includes screening, two treatment periods, and follow-up, with detailed monitoring to understand treatment effects and safety in this population.
CONDITIONS
Brief Title
Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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