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

December 19, 2025 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1119ACN
        • Recruiting
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1121ABE
        • Recruiting
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DBS
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5K 1X3
        • Recruiting
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • Recruiting
        • Novartis Investigative Site
      • Markham, Ontario, Canada, L3P 1X3
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Recruiting
        • Novartis Investigative Site
      • Verdun, Quebec, Canada, H4G 3E7
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100050
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100029
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Recruiting
        • Novartis Investigative Site
      • Shantou, Guangdong, China, 515000
        • Recruiting
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310001
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Plzen Bory, Czechia, 301 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 150 06
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 100 34
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 130 00
        • Recruiting
        • Novartis Investigative Site
  • France
      • Brest, France, 29609
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Recruiting
        • Novartis Investigative Site
      • Lorient, France, 56322
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75475
        • Recruiting
        • Novartis Investigative Site
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Novartis Investigative Site
      • Reims, France, 51100
        • Recruiting
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • Recruiting
        • Novartis Investigative Site
      • Dresden, Germany, 01097
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
      • Oldenburg, Germany, 26133
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55128
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1033
        • Recruiting
        • Novartis Investigative Site
      • Budapest, Hungary, H-1083
        • Recruiting
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Recruiting
        • Novartis Investigative Site
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Recruiting
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44124
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Fukuoka, Japan, 8128582
        • Active, not recruiting
        • Novartis Investigative Site
      • Kyoto, Japan, 6078062
        • Recruiting
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4678602
        • Recruiting
        • Novartis Investigative Site
    • Chiba
      • Matsudo, Chiba, Japan, 2710092
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-0063
        • Recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 220-6208
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Habikino, Osaka, Japan, 583 8588
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Shinagawa Ku, Tokyo, Japan, 141 8625
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Katowice, Poland, 40-611
        • Recruiting
        • Novartis Investigative Site
      • Lodz, Poland, 90-436
        • Recruiting
        • Novartis Investigative Site
      • Lublin, Poland, 20-573
        • Recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 02-962
        • Recruiting
        • Novartis Investigative Site
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-953
        • Recruiting
        • Novartis Investigative Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Recruiting
        • Novartis Investigative Site
      • Komárno, Slovakia, 945 01
        • Recruiting
        • Novartis Investigative Site
      • Košice, Slovakia, 040 22
        • Recruiting
        • Novartis Investigative Site
      • Košice, Slovakia, 041 90
        • Recruiting
        • Novartis Investigative Site
      • Prešov, Slovakia, 080 01
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, South Korea, 425-801
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • Novartis Investigative Site
      • Granada, Spain, 18016
        • Recruiting
        • Novartis Investigative Site
      • Las Palmas GC, Spain, 35010
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Recruiting
        • Novartis Investigative Site
      • Pontevedra, Spain, 36003
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Novartis Investigative Site
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Novartis Investigative Site
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Novartis Investigative Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Recruiting
        • Novartis Investigative Site
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90056
        • Recruiting
        • Novartis Investigative Site
      • Sacramento, California, United States, 95815
        • Recruiting
        • Novartis Investigative Site
      • Santa Ana, California, United States, 92701
        • Recruiting
        • Novartis Investigative Site
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Novartis Investigative Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20060
        • Recruiting
        • Novartis Investigative Site
    • Florida
      • Miami, Florida, United States, 33144
        • Recruiting
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Novartis Investigative Site
      • Macon, Georgia, United States, 31217
        • Recruiting
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Novartis Investigative Site
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Recruiting
        • Novartis Investigative Site
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Novartis Investigative Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Novartis Investigative Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Recruiting
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Recruiting
        • Novartis Investigative Site
      • Cypress, Texas, United States, 77433
        • Recruiting
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75235-9069
        • Recruiting
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78218
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: GHZ339
GHZ339 administered at dose A, B, C and D
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
Drug: GHZ339
GHZ339 administered at dose A, B, C and D
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
Drug: GHZ339
GHZ339 administered at dose A, B, C and D
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
Drug: GHZ339
GHZ339 administered at dose A, B, C and D
Placebo Comparator: Placebo
Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Drug: Placebo
Matching placebo
Drug: GHZ339
GHZ339 administered at dose A, B, C and D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
Time Frame: Baseline, Week 16
EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
Baseline, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EASI-75 response at Week 16
Time Frame: Baseline, Week 16

EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.

EASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline.
Baseline, Week 16
Investigator Global Assessment (IGA) response at Week 16
Time Frame: Baseline, Week 16

The IGA rating scale will be used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The IGA score ranges from 0 (clear) to 4 (severe).

IGA response is defined as clear or almost clear score with at least a 2 point-reduction from baseline
Baseline, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Estimated)

November 27, 2028

Study Completion (Estimated)

December 22, 2028

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CADPT17A12201
  • 2024-519081-49 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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