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

NCT ID: NCT06947993

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2028-12-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Atopic Dermatitis

Keywords

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Atopic dermatitis Dermatitis Eczema Moderate to severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

GHZ339

Intervention Type DRUG

GHZ339 administered at dose A, B, C and D

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

Group Type EXPERIMENTAL

GHZ339

Intervention Type DRUG

GHZ339 administered at dose A, B, C and D

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

Group Type EXPERIMENTAL

GHZ339

Intervention Type DRUG

GHZ339 administered at dose A, B, C and D

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

Group Type EXPERIMENTAL

GHZ339

Intervention Type DRUG

GHZ339 administered at dose A, B, C and D

Placebo

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

Group Type PLACEBO_COMPARATOR

GHZ339

Intervention Type DRUG

GHZ339 administered at dose A, B, C and D

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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GHZ339

GHZ339 administered at dose A, B, C and D

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status RECRUITING

Novartis Investigative Site

Birmingham, Alabama, United States

Site Status RECRUITING

Novartis Investigative Site

Fort Smith, Arkansas, United States

Site Status RECRUITING

Novartis Investigative Site

Fountain Valley, California, United States

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Novartis Investigative Site

Los Angeles, California, United States

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Novartis Investigative Site

Sacramento, California, United States

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Novartis Investigative Site

Santa Ana, California, United States

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Novartis Investigative Site

Santa Monica, California, United States

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Novartis Investigative Site

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

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Novartis Investigative Site

Miami, Florida, United States

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Novartis Investigative Site

Atlanta, Georgia, United States

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Novartis Investigative Site

Macon, Georgia, United States

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Novartis Investigative Site

Louisville, Kentucky, United States

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Novartis Investigative Site

Brighton, Massachusetts, United States

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Novartis Investigative Site

Troy, Michigan, United States

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Novartis Investigative Site

Saint Joseph, Missouri, United States

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Novartis Investigative Site

Brooklyn, New York, United States

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Novartis Investigative Site

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

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

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Novartis Investigative Site

Edmonton, Alberta, Canada

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Novartis Investigative Site

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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Novartis Investigative Site

Fukuoka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

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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Novartis Investigative Site

Ansan, Gyeonggi-do, South Korea

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Seoul, , South Korea

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Novartis Investigative Site

Badalona, Barcelona, Spain

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Novartis Investigative Site

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

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Novartis Investigative Site

Pontevedra, , Spain

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Novartis Investigative Site

Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Novartis Investigative Site

Dudley, West Midlands, United Kingdom

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Novartis Investigative Site

Liverpool, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Canada China Czechia France Germany Hungary Italy Japan Netherlands Poland Slovakia South Korea Spain Taiwan United Kingdom

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Other Identifiers

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2024-519081-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CADPT17A12201

Identifier Type: -

Identifier Source: org_study_id