Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis

Phase 2

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: GHZ339; Drug: Placebo

• Registration Number: NCT06947993
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD.

The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-07-01
• Primary Completion: 2028-11-27
• Study Completion: 2028-11-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GHZ339 Dose A	GHZ339	Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
GHZ339 Dose B	GHZ339	Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2
GHZ339 Dose C	GHZ339	Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2
GHZ339 Dose D	GHZ339	Participants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2
Placebo	GHZ339	Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Placebo	Placebo	Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16	Baseline, Week 16	EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.

Secondary Outcome Measures

Name	Time	Method
EASI-75 response at Week 16	Baseline, Week 16	EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.; EASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline.
Investigator Global Assessment (IGA) response at Week 16	Baseline, Week 16	The IGA rating scale will be used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The IGA score ranges from 0 (clear) to 4 (severe).; IGA response is defined as clear or almost clear score with at least a 2 point-reduction from baseline