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NCT06947993PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

5/16/2025

Completion Date

12/22/2028

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.

Eligibility Criteria

Age Range: 18 years to 100 years

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

Interventions

DRUG

GHZ339

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Atopic Dermatitis

Locations

Novartis Investigative Site

Birmingham, Alabama 35233

United States

Novartis Investigative Site

Birmingham, Alabama 35244

United States

Novartis Investigative Site

Fort Smith, Arkansas 72916

United States

Novartis Investigative Site

Fountain Valley, California 92708

United States

Novartis Investigative Site

Los Angeles, California 90056

United States

Novartis Investigative Site

Sacramento, California 95815

United States

Novartis Investigative Site

Santa Ana, California 92701

United States

Novartis Investigative Site

Santa Monica, California 90404

United States

Novartis Investigative Site

Washington D.C., District of Columbia 20060

United States

Novartis Investigative Site

Miami, Florida 33144

United States

Novartis Investigative Site

Atlanta, Georgia 30342

United States

Novartis Investigative Site

Macon, Georgia 31217

United States

Novartis Investigative Site

Louisville, Kentucky 40241

United States

Novartis Investigative Site

Brighton, Massachusetts 02135

United States

Novartis Investigative Site

Troy, Michigan 48084

United States

Novartis Investigative Site

Saint Joseph, Missouri 64506

United States

Novartis Investigative Site

Brooklyn, New York 11203

United States

Novartis Investigative Site

Arlington, Texas 76011

United States

Novartis Investigative Site

Cypress, Texas 77433

United States

Novartis Investigative Site

Dallas, Texas 75235-9069

United States

Novartis Investigative Site

Houston, Texas 77030

United States

Novartis Investigative Site

San Antonio, Texas 78218

United States

Novartis Investigative Site

Caba, Buenos Aires C1119ACN

Argentina

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Caba, Buenos Aires C1121ABE

Argentina

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Rosario, Santa Fe Province S2000DBS

Argentina

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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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Montreal, Quebec H1Y 3L1

Canada

Novartis Investigative Site

Verdun, Quebec H4G 3E7

Canada

Novartis Investigative Site

Guangzhou, Guangdong 510091

China

Novartis Investigative Site

Shantou, Guangdong 515000

China

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Changsha, Hunan 410008

China

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Changchun, Jilin 130021

China

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Hangzhou, Zhejiang 310001

China

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Beijing, 100029

China

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Beijing, 100050

China

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Shanghai, 200040

China

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Plzen Bory, 301 00

Czechia

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Prague, 100 34

Czechia

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Prague, 130 00

Czechia

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Prague, 150 06

Czechia

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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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Pierre-Bénite, 69495

France

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Reims, 51100

France

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Rouen, 76031

France

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Frankfurt am Main, Hesse 60590

Germany

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Mainz, Rhineland-Palatinate 55128

Germany

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Bad Bentheim, 48455

Germany

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Dresden, 01097

Germany

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Hamburg, 20246

Germany

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Heidelberg, 69120

Germany

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Magdeburg, 39120

Germany

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Münster, 48149

Germany

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Oldenburg, 26133

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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Ancona, AN 60126

Italy

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Cona, FE 44124

Italy

Novartis Investigative Site

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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Habikino, Osaka 583 8588

Japan

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Shinagawa Ku, Tokyo 141 8625

Japan

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Fukuoka, 8128582

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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Warsaw, Masovian Voivodeship 02-953

Poland

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Katowice, 40-611

Poland

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Lodz, 90-436

Poland

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Lublin, 20-573

Poland

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Warsaw, 02-962

Poland

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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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Prešov, 080 01

Slovakia

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Ansan, Gyeonggi-do 425-801

South Korea

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Seoul, 03722

South Korea

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Badalona, Barcelona 08916

Spain

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Alicante, 03010

Spain

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Granada, 18016

Spain

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Las Palmas GC, 35010

Spain

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Madrid, 28006

Spain

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Madrid, 28041

Spain

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Pontevedra, 36003

Spain

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Kaohsiung City, 83301

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 11217

Taiwan

Novartis Investigative Site

Dudley, West Midlands DY1 2HQ

United Kingdom

Novartis Investigative Site

Liverpool, L7 8XP

United Kingdom