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Atopic DermatitisPhase 2NCT06947993

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

A Phase 2 study testing GHZ339 in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 105 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
GHZ339
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
105 sitesin 17 countries
Study dates
16 May 2025to 22 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

105 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

105 sites in 17 countries

United States24 sites, 24 recruiting

  • Novartis Investigative Site

    Arlington, Texas, 76011

    Recruiting

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

    Recruiting

  • Novartis Investigative Site

    Birmingham, Alabama, 35233

    Recruiting

  • Novartis Investigative Site

    Birmingham, Alabama, 35244

    Recruiting

  • Novartis Investigative Site

    Brighton, Massachusetts, 02135

    Recruiting

  • Novartis Investigative Site

    Brooklyn, New York, 11203

    Recruiting

  • Novartis Investigative Site

    Cypress, Texas, 77433

    Recruiting

  • Novartis Investigative Site

    Dallas, Texas, 75235-9069

    Recruiting

  • Novartis Investigative Site

    Fort Smith, Arkansas, 72916

    Recruiting

  • Novartis Investigative Site

    Fountain Valley, California, 92708

    Recruiting

  • Novartis Investigative Site

    Houston, Texas, 77030

    Recruiting

  • Novartis Investigative Site

    Los Angeles, California, 90056

    Recruiting

  • Novartis Investigative Site

    Louisville, Kentucky, 40241

    Recruiting

  • Novartis Investigative Site

    Macon, Georgia, 31217

    Recruiting

  • Novartis Investigative Site

    Miami, Florida, 33144

    Recruiting

  • Novartis Investigative Site

    Portsmouth, New Hampshire, 03801

    Recruiting

  • Novartis Investigative Site

    Sacramento, California, 95815

    Recruiting

  • Novartis Investigative Site

    Saint Joseph, Missouri, 64506

    Recruiting

  • Novartis Investigative Site

    San Antonio, Texas, 78218

    Recruiting

  • Novartis Investigative Site

    Santa Ana, California, 92701

    Recruiting

  • Novartis Investigative Site

    Santa Monica, California, 90404

    Recruiting

  • Novartis Investigative Site

    St. Petersburg, Florida, 33705

    Recruiting

  • Novartis Investigative Site

    Troy, Michigan, 48084

    Recruiting

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20060

    Recruiting

Other trials in United States

Germany9 sites, 1 recruiting

  • Novartis Investigative Site

    Bad Bentheim, 48455

    Active, not recruiting

  • Novartis Investigative Site

    Dresden, 01097

    Active, not recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

    Active, not recruiting

  • Novartis Investigative Site

    Hamburg, 20246

    Recruiting

  • Novartis Investigative Site

    Heidelberg, 69120

    Active, not recruiting

  • Novartis Investigative Site

    Magdeburg, 39120

    Active, not recruiting

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55128

    Active, not recruiting

  • Novartis Investigative Site

    Münster, 48149

    Active, not recruiting

  • Novartis Investigative Site

    Oldenburg, 26133

    Active, not recruiting

Other trials in Germany

China8 sites, 2 recruiting

  • Novartis Investigative Site

    Beijing, 100029

    Withdrawn

  • Novartis Investigative Site

    Beijing, 100050

    Active, not recruiting

  • Novartis Investigative Site

    Changchun, Jilin, 130021

    Active, not recruiting

  • Novartis Investigative Site

    Changsha, Hunan, 410008

    Active, not recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510091

    Active, not recruiting

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310001

    Recruiting

  • Novartis Investigative Site

    Shanghai, 200040

    Recruiting

  • Novartis Investigative Site

    Shantou, Guangdong, 515000

    Active, not recruiting

Other trials in China

Japan8 sites, 6 recruiting

  • Novartis Investigative Site

    Fukuoka, 8128582

    Active, not recruiting

  • Novartis Investigative Site

    Habikino, Osaka, 5838588

    Recruiting

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 211-0063

    Recruiting

  • Novartis Investigative Site

    Kyoto, 6078062

    Recruiting

  • Novartis Investigative Site

    Matsudo, Chiba, 2710092

    Recruiting

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4678602

    Recruiting

  • Novartis Investigative Site

    Shinagawa Ku, Tokyo, 1418625

    Active, not recruiting

  • Novartis Investigative Site

    Yokohama, Kanagawa, 220-6208

    Recruiting

Other trials in Japan

France7 sites, 7 recruiting

  • Novartis Investigative Site

    Brest, 29609

    Recruiting

  • Novartis Investigative Site

    Lille, 59037

    Recruiting

  • Novartis Investigative Site

    Lorient, 56322

    Recruiting

  • Novartis Investigative Site

    Paris, 75475

    Recruiting

  • Novartis Investigative Site

    Pierre-Bénite, 69495

    Recruiting

  • Novartis Investigative Site

    Reims, 51100

    Recruiting

  • Novartis Investigative Site

    Rouen, 76031

    Recruiting

Other trials in France

Spain7 sites, 7 recruiting

  • Novartis Investigative Site

    Alicante, 03010

    Recruiting

  • Novartis Investigative Site

    Badalona, Barcelona, 08916

    Recruiting

  • Novartis Investigative Site

    Granada, 18016

    Recruiting

  • Novartis Investigative Site

    Las Palmas GC, 35010

    Recruiting

  • Novartis Investigative Site

    Madrid, 28006

    Recruiting

  • Novartis Investigative Site

    Madrid, 28041

    Recruiting

  • Novartis Investigative Site

    Pontevedra, 36003

    Recruiting

Other trials in Spain

Canada5 sites, 3 recruiting

  • Novartis Investigative Site

    Edmonton, Alberta, T5K 1X3

    Active, not recruiting

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3

    Recruiting

  • Novartis Investigative Site

    Markham, Ontario, L3P 1X3

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H1Y 3L1

    Recruiting

  • Novartis Investigative Site

    Verdun, Quebec, H4G 3E7

    Active, not recruiting

Other trials in Canada

Czechia5 sites, 5 recruiting

  • Novartis Investigative Site

    Plzen Bory, 301 00

    Recruiting

  • Novartis Investigative Site

    Prague, 100 34

    Recruiting

  • Novartis Investigative Site

    Prague, 130 00

    Recruiting

  • Novartis Investigative Site

    Prague, 150 06

    Recruiting

  • Novartis Investigative Site

    Prague, 180 81

    Recruiting

Other trials in Czechia

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1033

    Active, not recruiting

  • Novartis Investigative Site

    Budapest, 1083

    Active, not recruiting

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

    Active, not recruiting

  • Novartis Investigative Site

    Pécs, Baranya, 7623

    Active, not recruiting

  • Novartis Investigative Site

    Szeged, 6725

    Active, not recruiting

Other trials in Hungary

Poland5 sites

  • Novartis Investigative Site

    Katowice, 40-611

    Active, not recruiting

  • Novartis Investigative Site

    Lodz, 90-436

    Active, not recruiting

  • Novartis Investigative Site

    Lublin, 20-573

    Active, not recruiting

  • Novartis Investigative Site

    Warsaw, Masovian Voivodeship, 02-953

    Active, not recruiting

  • Novartis Investigative Site

    Warsaw, 02-962

    Active, not recruiting

Other trials in Poland

Slovakia5 sites, 3 recruiting

  • Novartis Investigative Site

    Bardejov, 085 01

    Withdrawn

  • Novartis Investigative Site

    Komárno, 945 01

    Recruiting

  • Novartis Investigative Site

    Košice, 040 22

    Active, not recruiting

  • Novartis Investigative Site

    Košice, 041 90

    Recruiting

  • Novartis Investigative Site

    Prešov, 080 01

    Recruiting

Other trials in Slovakia

Taiwan4 sites, 4 recruiting

  • Novartis Investigative Site

    Kaohsiung City, 833

    Recruiting

  • Novartis Investigative Site

    Taipei, 10002

    Recruiting

  • Novartis Investigative Site

    Taipei, 11217

    Recruiting

  • Novartis Investigative Site

    Taipei, 11490

    Recruiting

Other trials in Taiwan

Argentina3 sites, 3 recruiting

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN

    Recruiting

  • Novartis Investigative Site

    Caba, Buenos Aires, C1121ABE

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

    Recruiting

Other trials in Argentina

Italy3 sites, 1 recruiting

  • Novartis Investigative Site

    Ancona, AN, 60020

    Active, not recruiting

  • Novartis Investigative Site

    Cona, FE, 44124

    Active, not recruiting

  • Novartis Investigative Site

    Pisa, PI, 56126

    Recruiting

Other trials in Italy

United Kingdom3 sites

  • Novartis Investigative Site

    Dudley, West Midlands, DY1 2HQ

    Suspended

  • Novartis Investigative Site

    Liverpool, L7 8XP

    Active, not recruiting

  • Novartis Investigative Site

    London, SE1 9RT

    Active, not recruiting

Other trials in United Kingdom

Netherlands2 sites, 1 recruiting

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD

    Active, not recruiting

  • Novartis Investigative Site

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

South Korea2 sites, 2 recruiting

  • Novartis Investigative Site

    Ansan, Gyeonggi-do, 15355

    Recruiting

  • Novartis Investigative Site

    Seoul, 03722

    Recruiting

Other trials in South Korea

About this study

Official title: 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).

Read the 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.

Being tested
GHZ339, Placebo
Keywords
Atopic dermatitis, Dermatitis, Eczema, Moderate to severe
Medical subject headings
Dermatitis, Atopic, Dermatitis, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GHZ339Drug

    GHZ339 administered at dose A, B, C and D

  • PlaceboDrug

    Matching placebo

Study groups in NCT06947993
Study groupRoleWhat they receive
GHZ339 Dose AExperimentalParticipants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Receives: Drug: GHZ339
GHZ339 Dose BExperimentalParticipants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2
Receives: Drug: GHZ339
GHZ339 Dose CExperimentalParticipants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2
Receives: Drug: GHZ339
GHZ339 Dose DExperimentalParticipants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2
Receives: Drug: GHZ339
PlaceboPlacebo comparatorParticipants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Receives: Drug: GHZ339; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 16

Secondary outcomes (2)

  1. EASI-75 response 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.

    EASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline.

    Measured: Baseline, Week 16

  2. Investigator Global Assessment (IGA) response at 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

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start16 May 2025
  3. Primary completion27 Nov 2028 (estimated)
  4. Study completion22 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06947993
Sponsor's protocol ID
CADPT17A12201
Other IDs
2024-519081-49-00
Status last verified
Sep 2026
First submitted
25 Apr 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GHZ339 in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 105 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Germany, China, Japan, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06947993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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