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

Last Update: Dec 22, 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:

NCT06947993

Novartis Reference Number:CADPT17A12201

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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.

Condition

Atopic Dermatitis

Phase

Phase2

Overall Status

Recruiting

Number of Participants

224

Start Date

May 16, 2025

Completion Date

Dec 22, 2028

Gender

All

Age(s)

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

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Rosario,Santa Fe Province,S2000dbs,Argentina

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Caba,Buenos Aires,C1121abe,Argentina

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Caba,Buenos Aires,C1119acn,Argentina

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Montreal,Quebec,H1y 3l1,Canada

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Verdun,Quebec,H4g 3e7,Canada

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Edmonton,Alberta,T5k 1x3,Canada

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Hamilton,Ontario,L8l 3c3,Canada

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Markham,Ontario,L3p 1x3,Canada

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Changchun,Jilin,130021,China

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Shanghai,200040,China

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Beijing,100029,China

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Beijing,100050,China

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Hangzhou,Zhejiang,310001,China

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Changsha,Hunan,410008,China

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Guangzhou,Guangdong,510091,China

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Shantou,Guangdong,515000,China

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Plzen Bory,301 00,Czechia

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Prague,150 06,Czechia

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Prague,130 00,Czechia

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Prague,100 34,Czechia

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Pierre-Bénite,69495,France

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Brest,29609,France

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Lille,59037,France

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Lorient,56322,France

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Paris,75475,France

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Reims,51100,France

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Rouen,76031,France

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Heidelberg,69120,Germany

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Oldenburg,26133,Germany

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Münster,48149,Germany

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Magdeburg,39120,Germany

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Hamburg,20246,Germany

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Dresden,01097,Germany

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Bad Bentheim,48455,Germany

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Mainz,Rhineland-Palatinate,55128,Germany

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Frankfurt am Main,Hesse,60590,Germany

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Pécs,Baranya,7623,Hungary

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Debrecen,Hajdu Bihar Megye,4032,Hungary

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Budapest,1033,Hungary

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Budapest,H-1083,Hungary

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Szeged,6725,Hungary

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Cona,FE,44124,Italy

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Ancona,AN,60126,Italy

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Nagoya,Aichi-ken,4678602,Japan

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Matsudo,Chiba,2710092,Japan

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Kawasaki,Kanagawa,211-0063,Japan

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Yokohama,Kanagawa,220-6208,Japan

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Shinagawa Ku,Tokyo,141 8625,Japan

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Habikino,Osaka,583 8588,Japan

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Kyoto,6078062,Japan

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Rotterdam,South Holland,3015 gd,Netherlands

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Utrecht,3584 cx,Netherlands

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Lodz,90-436,Poland

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Warsaw,02-962,Poland

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Warsaw,Masovian Voivodeship,02-953,Poland

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Katowice,40-611,Poland

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Lublin,20-573,Poland

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Prešov,080 01,Slovakia

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Bardejov,085 01,Slovakia

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Komárno,945 01,Slovakia

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Košice,040 22,Slovakia

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Košice,041 90,Slovakia

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Ansan,Gyeonggi-do,425-801,South Korea

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Seoul,03722,South Korea

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Granada,18016,Spain

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Pontevedra,36003,Spain

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Madrid,28041,Spain

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Madrid,28006,Spain

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Las Palmas GC,35010,Spain

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Alicante,03010,Spain

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Badalona,Barcelona,08916,Spain

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Kaohsiung City,83301,Taiwan

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Taipei,10002,Taiwan

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Taipei,11217,Taiwan

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Dudley,West Midlands,Dy1 2hq,United Kingdom

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Liverpool,L7 8xp,United Kingdom

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San Antonio,Texas,78218,United States

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Birmingham,Alabama,35244,United States

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Los Angeles,California,90056,United States

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Miami,Florida,33144,United States

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Atlanta,Georgia,30342,United States

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Macon,Georgia,31217,United States

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Brighton,Massachusetts,02135,United States

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Troy,Michigan,48084,United States

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Saint Joseph,Missouri,64506,United States

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Arlington,Texas,76011,United States

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Cypress,Texas,77433,United States

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Dallas,Texas,75235-9069,United States

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Santa Ana,California,92701,United States

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Santa Monica,California,90404,United States

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Louisville,Kentucky,40241,United States

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Houston,Texas,77030,United States

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Birmingham,Alabama,35233,United States

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Fort Smith,Arkansas,72916,United States

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Fountain Valley,California,92708,United States

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Sacramento,California,95815,United States

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

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Brooklyn,New York,11203,United States

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Phone: +41613241111

Email:

Novartis Pharmaceuticals

Phone: 1-888-669-6682

Email: [email protected]