RecruitingPhase 2NCT06947993

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

224 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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

Exclusion Criteria5

  • 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)

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Interventions

DRUGGHZ339

GHZ339 administered at dose A, B, C and D

DRUGPlacebo

Matching placebo


Locations(99)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Fort Smith, Arkansas, United States

Novartis Investigative Site

Fountain Valley, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Sacramento, California, United States

Novartis Investigative Site

Santa Ana, California, United States

Novartis Investigative Site

Santa Monica, California, United States

Novartis Investigative Site

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

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Atlanta, Georgia, United States

Novartis Investigative Site

Macon, Georgia, United States

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Louisville, Kentucky, United States

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Brighton, Massachusetts, United States

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Troy, Michigan, United States

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Saint Joseph, Missouri, United States

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Brooklyn, New York, United States

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Arlington, Texas, United States

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Cypress, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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Markham, Ontario, Canada

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Montreal, Quebec, Canada

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Verdun, Quebec, Canada

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Guangzhou, Guangdong, China

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Shantou, Guangdong, China

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Changsha, Hunan, China

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Changchun, Jilin, China

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Hangzhou, Zhejiang, China

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Beijing, China

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Beijing, China

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Shanghai, China

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Plzen Bory, Czechia

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Prague, Czechia

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Prague, Czechia

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Prague, Czechia

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Brest, France

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Lille, France

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Lorient, France

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Paris, France

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Pierre-Bénite, France

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Reims, France

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Rouen, France

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Frankfurt am Main, Hesse, Germany

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Mainz, Rhineland-Palatinate, Germany

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Bad Bentheim, Germany

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Dresden, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Magdeburg, Germany

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Münster, Germany

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Oldenburg, Germany

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Pécs, Baranya, Hungary

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Debrecen, Hajdu Bihar Megye, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Szeged, Hungary

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Ancona, AN, Italy

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Cona, FE, Italy

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Nagoya, Aichi-ken, Japan

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Matsudo, Chiba, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Habikino, Osaka, Japan

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Shinagawa Ku, Tokyo, Japan

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Fukuoka, Japan

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Kyoto, Japan

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Rotterdam, South Holland, Netherlands

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Utrecht, Netherlands

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Warsaw, Masovian Voivodeship, Poland

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Katowice, Poland

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Lodz, Poland

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Lublin, Poland

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Warsaw, Poland

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Bardejov, Slovakia

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Komárno, Slovakia

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Košice, Slovakia

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Košice, Slovakia

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Prešov, Slovakia

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Ansan, Gyeonggi-do, South Korea

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Seoul, South Korea

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Badalona, Barcelona, Spain

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Alicante, Spain

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Granada, Spain

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Las Palmas GC, Spain

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Madrid, Spain

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Madrid, Spain

Novartis Investigative Site

Pontevedra, Spain

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Kaohsiung City, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Dudley, West Midlands, United Kingdom

Novartis Investigative Site

Liverpool, United Kingdom

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NCT06947993


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