Testing new treatments for moderate to severe atopic dermatitis
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
Run by Novartis · NCT06947993 · Data updated 2026-11-12
This trial will test an experimental medicine called GHZ339 (compared with placebo) to see if it reduces symptoms in people with moderate to severe atopic dermatitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 224 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 105 sites (Birmingham, Alabama and 104 other locations) |
| Status | Recruiting |
| Started | May 16, 2025 |
| Main results expected | November 27, 2028 |
| Study ends | December 22, 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06947993 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with a confirmed diagnosis of atopic dermatitis for at least one year who currently have moderate to severe disease and can provide informed consent.
✕Probably not a fit
People with other active inflammatory skin diseases, uncontrolled chronic medical conditions, significant lab/ECG abnormalities, or other exclusionary conditions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform designed to test multiple investigational compounds in participants with moderate to severe atopic dermatitis. The platform design allows different interventions to be added and compared over time; the first planned intervention is GHZ339. Eligible participants have had AD for at least one year and meet criteria for moderate to severe disease, with additional safety-related exclusions for significant medical conditions or abnormal labs. Participants are randomly assigned to study arms and followed for efficacy and safety outcomes.
Why it matters
Potential benefit: If successful, the intervention could become an additional safe and effective option to reduce itching, inflammation, and skin lesions in people with moderate to severe atopic dermatitis.
How similar studies have gone: Other targeted therapies and small molecules for moderate-to-severe atopic dermatitis have shown clinical benefit, but GHZ339 is a new investigational compound being tested in this platform.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Novartis Investigative Site
Birmingham, Alabama, United States Recruiting -
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Birmingham, Alabama, United States Recruiting -
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Fort Smith, Arkansas, United States Recruiting -
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Fountain Valley, California, United States Recruiting -
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Los Angeles, California, United States Recruiting -
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Sacramento, California, United States Recruiting
Show 44 more locations
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Santa Ana, California, United States Recruiting -
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Santa Monica, California, United States Recruiting -
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Washington D.C., District of Columbia, United States Recruiting -
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Miami, Florida, United States Recruiting -
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St. Petersburg, Florida, United States Recruiting -
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Atlanta, Georgia, United States Recruiting -
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Macon, Georgia, United States Recruiting -
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Louisville, Kentucky, United States Recruiting -
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Brighton, Massachusetts, United States Recruiting -
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Troy, Michigan, United States Recruiting -
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Saint Joseph, Missouri, United States Recruiting -
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Portsmouth, New Hampshire, United States Recruiting -
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Brooklyn, New York, United States Recruiting -
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Arlington, Texas, United States Recruiting -
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Cypress, Texas, United States Recruiting -
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Dallas, Texas, United States Recruiting -
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Houston, Texas, United States Recruiting -
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San Antonio, Texas, United States Recruiting -
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Caba, Buenos Aires, Argentina Recruiting -
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Caba, Buenos Aires, Argentina Recruiting -
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Rosario, Santa Fe Province, Argentina Recruiting -
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Hamilton, Ontario, Canada Recruiting -
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Markham, Ontario, Canada Recruiting -
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Montreal, Quebec, Canada Recruiting -
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Hangzhou, Zhejiang, China Recruiting -
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Shanghai, China Recruiting -
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Plzen Bory, Czechia Recruiting -
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Prague, Czechia Recruiting -
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Prague, Czechia Recruiting -
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Prague, Czechia Recruiting -
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Prague, Czechia Recruiting -
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Brest, France Recruiting -
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Lille, France Recruiting -
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Lorient, France Recruiting -
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Paris, France Recruiting -
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Pierre-Bénite, France Recruiting -
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Reims, France Recruiting -
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Rouen, France Recruiting -
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Hamburg, Germany Recruiting -
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Pisa, Pi, Italy Recruiting -
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Nagoya, Aichi-ken, Japan Recruiting -
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Matsudo, Chiba, Japan Recruiting -
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Kawasaki, Kanagawa, Japan Recruiting -
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Yokohama, Kanagawa, Japan Recruiting
+55 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults
A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.
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Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin
This study tests whether the Replior ScratchSense ring can accurately detect and measure nighttime scratching in adults with itchy skin conditions.
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ADBest TREAT Registry for adults with atopic dermatitis
A registry in Germany is collecting real-world data from adults with atopic dermatitis to see how treatments are used and how the disease affects quality of life.
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How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis
This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.
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QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis
This study tests the safety and tolerability of QX-4533, given as a pill, in healthy adults and in patients with moderate-to-severe atopic dermatitis to see how the drug behaves in the body and what side effects may occur.
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Tilrekimig for moderate-to-severe eczema in teens and adults
A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.