Recruiting

Phase 2

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06947993

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

GHZ339

Placebo

Study Details

Brief summary:

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

Conditions

Atopic Dermatitis

Study ID

NCT06947993

Start date

May 16, 2025

Status verified date

Aug, 2026

Completion date

Dec 22, 2028

Anticipated

Primary completion date

Nov 27, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GHZ339 Dose A

Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2

experimental: GHZ339 Dose B

Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2

experimental: GHZ339 Dose C

Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2

experimental: GHZ339 Dose D

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 comparator: Placebo

Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2

Interventions

GHZ339

GHZ339 administered at dose A, B, C and D

Placebo

Matching placebo

Primary outcome measure

Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 [ Time Frame: Baseline, Week 16 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Novartis Investigative Site

Recruiting

Birmingham, Alabama, United States, 35233

Novartis Investigative Site

Recruiting

Birmingham, Alabama, United States, 35244

Novartis Investigative Site

Recruiting

Fort Smith, Arkansas, United States, 72916

Novartis Investigative Site

Recruiting

Fountain Valley, California, United States, 92708

Novartis Investigative Site

Recruiting

Los Angeles, California, United States, 90056

Novartis Investigative Site

Recruiting

Sacramento, California, United States, 95815

Novartis Investigative Site

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Santa Ana, California, United States, 92701

Novartis Investigative Site

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Santa Monica, California, United States, 90404

Novartis Investigative Site

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Washington D.C., District of Columbia, United States, 20060

Novartis Investigative Site

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Miami, Florida, United States, 33144

Novartis Investigative Site

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St. Petersburg, Florida, United States, 33705

Novartis Investigative Site

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Atlanta, Georgia, United States, 30342

Novartis Investigative Site

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Macon, Georgia, United States, 31217

Novartis Investigative Site

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Louisville, Kentucky, United States, 40241

Novartis Investigative Site

Recruiting

Brighton, Massachusetts, United States, 02135

Novartis Investigative Site

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Troy, Michigan, United States, 48084

Novartis Investigative Site

Recruiting

Saint Joseph, Missouri, United States, 64506

Novartis Investigative Site

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Portsmouth, New Hampshire, United States, 03801

Novartis Investigative Site

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Brooklyn, New York, United States, 11203

Novartis Investigative Site

Recruiting

Arlington, Texas, United States, 76011

Novartis Investigative Site

Recruiting

Cypress, Texas, United States, 77433

Novartis Investigative Site

Recruiting

Dallas, Texas, United States, 75235-9069

Novartis Investigative Site

Recruiting

Houston, Texas, United States, 77030

Novartis Investigative Site

Recruiting

San Antonio, Texas, United States, 78218

Novartis Investigative Site

Recruiting

Hamilton, Ontario, Canada, L8L 3C3

Novartis Investigative Site

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Markham, Ontario, Canada, L3P 1X3

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H1Y 3L1

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Atopic dermatitis
Dermatitis
Eczema
Moderate to severe

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-19.