Last Update: Jun 12, 2025
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov Identifier:
Novartis Reference Number:CADPT17A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Atopic Dermatitis
Phase2
Recruiting
224
May 16, 2025
Nov 27, 2028
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

GHZ339

GHZ339 administered at dose A, B, C and D
Drug

Placebo

Matching placebo

Eligibility Criteria

Key Inclusion Criteria of the master protocol:

* Able and willing to sign the informed consent (IC)
* Patients with a diagnosis of AD and onset of disease for at least 1 year
* Moderate to severe AD

Key Exclusion Criteria of the master protocol:

* Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)
* Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG
* Participant with any other active inflammatory skin disease
* Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)
* Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)

Additional inclusion and exclusion criteria may apply depending on the intervention specific requirements

Novartis Investigative Site

Recruiting

Troy,Michigan,48084,United States

Novartis Investigative Site

Recruiting

Birmingham,Alabama,35244,United States

Novartis Investigative Site

Recruiting

Saint Joseph,Missouri,64506,United States

Novartis Investigative Site

Recruiting

Los Angeles,California,90056,United States

Novartis Investigative Site

Recruiting

Arlington,Texas,76011,United States

Novartis Investigative Site

Recruiting

Miami,Florida,33144,United States

Novartis Investigative Site

Recruiting

Cypress,Texas,77433,United States

Novartis Investigative Site

Recruiting

Atlanta,Georgia,30342,United States

Novartis Investigative Site

Recruiting

San Antonio,Texas,78218,United States

Novartis Investigative Site

Recruiting

Macon,Georgia,31217,United States

Novartis Investigative Site

Recruiting

Brighton,Massachusetts,02135,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals