Testing new treatments for moderate to severe atopic dermatitis
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 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 |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 99 sites (Birmingham, Alabama and 98 other locations) |
| Trial ID | NCT06947993 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 98 other locations
- Novartis Investigative Site — Birmingham, Alabama, United States (Recruiting)
- Novartis Investigative Site — Birmingham, Alabama, United States (Recruiting)
- Novartis Investigative Site — Fort Smith, Arkansas, United States (Recruiting)
- Novartis Investigative Site — Fountain Valley, California, United States (Recruiting)
- Novartis Investigative Site — Los Angeles, California, United States (Recruiting)
- Novartis Investigative Site — Sacramento, California, United States (Recruiting)
- Novartis Investigative Site — Santa Ana, California, United States (Recruiting)
- Novartis Investigative Site — Santa Monica, California, United States (Recruiting)
- Novartis Investigative Site — Washington D.C., District of Columbia, United States (Recruiting)
- Novartis Investigative Site — Miami, Florida, United States (Recruiting)
- Novartis Investigative Site — Atlanta, Georgia, United States (Recruiting)
- Novartis Investigative Site — Macon, Georgia, United States (Recruiting)
- Novartis Investigative Site — Louisville, Kentucky, United States (Recruiting)
- Novartis Investigative Site — Brighton, Massachusetts, United States (Recruiting)
- Novartis Investigative Site — Troy, Michigan, United States (Recruiting)
- Novartis Investigative Site — Saint Joseph, Missouri, United States (Recruiting)
- Novartis Investigative Site — Brooklyn, New York, United States (Recruiting)
- Novartis Investigative Site — Arlington, Texas, United States (Recruiting)
- Novartis Investigative Site — Cypress, Texas, United States (Recruiting)
- Novartis Investigative Site — Dallas, Texas, United States (Recruiting)
- Novartis Investigative Site — Houston, Texas, United States (Recruiting)
- Novartis Investigative Site — San Antonio, Texas, United States (Recruiting)
- Novartis Investigative Site — Caba, Buenos Aires, Argentina (Recruiting)
- Novartis Investigative Site — Caba, Buenos Aires, Argentina (Recruiting)
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina (Recruiting)
- Novartis Investigative Site — Edmonton, Alberta, Canada (Recruiting)
- Novartis Investigative Site — Hamilton, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Markham, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Montreal, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Verdun, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Guangzhou, Guangdong, China (Recruiting)
- Novartis Investigative Site — Shantou, Guangdong, China (Recruiting)
- Novartis Investigative Site — Changsha, Hunan, China (Recruiting)
- Novartis Investigative Site — Changchun, Jilin, China (Recruiting)
- Novartis Investigative Site — Hangzhou, Zhejiang, China (Recruiting)
- Novartis Investigative Site — Beijing, China (Recruiting)
- Novartis Investigative Site — Beijing, China (Recruiting)
- Novartis Investigative Site — Shanghai, China (Recruiting)
- Novartis Investigative Site — Plzen Bory, Czechia (Recruiting)
- Novartis Investigative Site — Prague, Czechia (Recruiting)
- Novartis Investigative Site — Prague, Czechia (Recruiting)
- Novartis Investigative Site — Prague, Czechia (Recruiting)
- Novartis Investigative Site — Brest, France (Recruiting)
- Novartis Investigative Site — Lille, France (Recruiting)
- Novartis Investigative Site — Lorient, France (Recruiting)
- Novartis Investigative Site — Paris, France (Recruiting)
- Novartis Investigative Site — Pierre-Bénite, France (Recruiting)
- Novartis Investigative Site — Reims, France (Recruiting)
- Novartis Investigative Site — Rouen, France (Recruiting)
- Novartis Investigative Site — Frankfurt am Main, Hesse, Germany (Recruiting)
+49 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.