NCT06947993

Brief Summary

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

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_2

Timeline
32mo left

Started May 2025

Typical duration for phase_2

Geographic Reach
17 countries

99 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
May 2025Dec 2028

First Submitted

Initial submission to the registry

April 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2028

Expected
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2028

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

April 25, 2025

Last Update Submit

December 19, 2025

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisDermatitisEczemaModerate to severe

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Eczema Area and Severity Index (EASI) score at 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 Outcomes (2)

  • EASI-75 response at Week 16

    Baseline, Week 16

  • Investigator Global Assessment (IGA) response at Week 16

    Baseline, Week 16

Study Arms (5)

GHZ339 Dose A

EXPERIMENTAL

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 Dose B

EXPERIMENTAL

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 Dose C

EXPERIMENTAL

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 Dose D

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: GHZ339Drug: Placebo

Interventions

GHZ339DRUG

GHZ339 administered at dose A, B, C and D

GHZ339 Dose AGHZ339 Dose BGHZ339 Dose CGHZ339 Dose DPlacebo
PlaceboDRUG

Matching placebo

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (99)

Novartis Investigative Site

Birmingham, Alabama, 35233, United States

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Novartis Investigative Site

Birmingham, Alabama, 35244, United States

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Novartis Investigative Site

Fort Smith, Arkansas, 72916, United States

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Novartis Investigative Site

Fountain Valley, California, 92708, United States

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Novartis Investigative Site

Los Angeles, California, 90056, United States

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Novartis Investigative Site

Sacramento, California, 95815, United States

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Novartis Investigative Site

Santa Ana, California, 92701, United States

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Novartis Investigative Site

Santa Monica, California, 90404, United States

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Novartis Investigative Site

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

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Novartis Investigative Site

Miami, Florida, 33144, United States

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Novartis Investigative Site

Atlanta, Georgia, 30342, United States

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Novartis Investigative Site

Macon, Georgia, 31217, United States

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Novartis Investigative Site

Louisville, Kentucky, 40241, United States

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Novartis Investigative Site

Brighton, Massachusetts, 02135, United States

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Novartis Investigative Site

Troy, Michigan, 48084, United States

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Novartis Investigative Site

Saint Joseph, Missouri, 64506, United States

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Novartis Investigative Site

Brooklyn, New York, 11203, United States

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Novartis Investigative Site

Arlington, Texas, 76011, United States

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Novartis Investigative Site

Cypress, Texas, 77433, United States

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Novartis Investigative Site

Dallas, Texas, 75235-9069, United States

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Novartis Investigative Site

Houston, Texas, 77030, United States

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Novartis Investigative Site

San Antonio, Texas, 78218, United States

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Novartis Investigative Site

Caba, Buenos Aires, C1119ACN, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1121ABE, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000DBS, Argentina

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Novartis Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

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Novartis Investigative Site

Hamilton, Ontario, L8L 3C3, Canada

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Novartis Investigative Site

Markham, Ontario, L3P 1X3, Canada

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Novartis Investigative Site

Montreal, Quebec, H1Y 3L1, Canada

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Novartis Investigative Site

Verdun, Quebec, H4G 3E7, Canada

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Novartis Investigative Site

Guangzhou, Guangdong, 510091, China

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Novartis Investigative Site

Shantou, Guangdong, 515000, China

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Novartis Investigative Site

Changsha, Hunan, 410008, China

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Novartis Investigative Site

Changchun, Jilin, 130021, China

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Novartis Investigative Site

Hangzhou, Zhejiang, 310001, China

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Novartis Investigative Site

Beijing, 100029, China

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Novartis Investigative Site

Beijing, 100050, China

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Novartis Investigative Site

Shanghai, 200040, China

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Novartis Investigative Site

Plzen Bory, 301 00, Czechia

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Novartis Investigative Site

Prague, 100 34, Czechia

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Novartis Investigative Site

Prague, 130 00, Czechia

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Novartis Investigative Site

Prague, 150 06, Czechia

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Novartis Investigative Site

Brest, 29609, France

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Novartis Investigative Site

Lille, 59037, France

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Novartis Investigative Site

Lorient, 56322, France

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Novartis Investigative Site

Paris, 75475, France

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Novartis Investigative Site

Pierre-Bénite, 69495, France

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Novartis Investigative Site

Reims, 51100, France

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Novartis Investigative Site

Rouen, 76031, France

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Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

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Novartis Investigative Site

Mainz, Rhineland-Palatinate, 55128, Germany

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Novartis Investigative Site

Bad Bentheim, 48455, Germany

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Novartis Investigative Site

Dresden, 01097, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

Magdeburg, 39120, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Oldenburg, 26133, Germany

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Novartis Investigative Site

Pécs, Baranya, 7623, Hungary

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Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

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Novartis Investigative Site

Budapest, 1033, Hungary

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Novartis Investigative Site

Budapest, H-1083, Hungary

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Novartis Investigative Site

Szeged, 6725, Hungary

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Cona, FE, 44124, Italy

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Novartis Investigative Site

Nagoya, Aichi-ken, 4678602, Japan

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Novartis Investigative Site

Matsudo, Chiba, 2710092, Japan

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Novartis Investigative Site

Kawasaki, Kanagawa, 211-0063, Japan

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Novartis Investigative Site

Yokohama, Kanagawa, 220-6208, Japan

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Novartis Investigative Site

Habikino, Osaka, 583 8588, Japan

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Novartis Investigative Site

Shinagawa Ku, Tokyo, 141 8625, Japan

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Novartis Investigative Site

Fukuoka, 8128582, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Kyoto, 6078062, Japan

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Novartis Investigative Site

Rotterdam, South Holland, 3015 GD, Netherlands

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Novartis Investigative Site

Utrecht, 3584 CX, Netherlands

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Novartis Investigative Site

Warsaw, Masovian Voivodeship, 02-953, Poland

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Novartis Investigative Site

Katowice, 40-611, Poland

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Novartis Investigative Site

Lodz, 90-436, Poland

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Novartis Investigative Site

Lublin, 20-573, Poland

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Novartis Investigative Site

Warsaw, 02-962, Poland

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Novartis Investigative Site

Bardejov, 085 01, Slovakia

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Novartis Investigative Site

Komárno, 945 01, Slovakia

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Novartis Investigative Site

Košice, 040 22, Slovakia

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Novartis Investigative Site

Košice, 041 90, Slovakia

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Novartis Investigative Site

Prešov, 080 01, Slovakia

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Novartis Investigative Site

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

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Novartis Investigative Site

Seoul, 03722, South Korea

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Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

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Novartis Investigative Site

Alicante, 03010, Spain

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Novartis Investigative Site

Granada, 18016, Spain

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Novartis Investigative Site

Las Palmas GC, 35010, Spain

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Novartis Investigative Site

Madrid, 28006, Spain

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Novartis Investigative Site

Madrid, 28041, Spain

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Novartis Investigative Site

Pontevedra, 36003, Spain

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Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

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Novartis Investigative Site

Taipei, 10002, Taiwan

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Novartis Investigative Site

Taipei, 11217, Taiwan

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Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

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Novartis Investigative Site

Liverpool, L7 8XP, United Kingdom

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MeSH Terms

Conditions

Dermatitis, AtopicDermatitisEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2025

First Posted

April 27, 2025

Study Start

May 16, 2025

Primary Completion (Estimated)

November 27, 2028

Study Completion (Estimated)

December 22, 2028

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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

Locations

PL(5)CA(5)ES(7)AR(3)KR(2)GB(2)TW(3)HU(5)IT(2)SL(5)DE(9)US(22)JP(8)NL(2)CN(8)FR(7)CZ(4)