GIA632 for adults with moderate to severe atopic dermatitis
A Multicenter, Randomized, Participant- and Investigator -Blinded, Placebo-controlled, Phase 2a Study to Assess the Efficacy, Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
This trial will try GIA632 in adults with moderate to severe atopic dermatitis to see if it improves symptoms and is safe and well tolerated compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 28 sites (Fremont, California and 27 other locations) |
| Trial ID | NCT07220577 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled, parallel-group Phase 2a study that enrolls adults with at least one year of moderate to severe atopic dermatitis. Participants and investigators are blinded to treatment assignment while receiving either GIA632 or placebo. The trial collects measures of skin signs, symptoms, safety labs, and adverse events to provide preliminary efficacy, safety, and tolerability data. Results will inform whether larger confirmatory trials are warranted.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of atopic dermatitis for at least one year who have moderate to severe disease and meet the study's health and laboratory criteria are the intended participants.
Not a fit: People with significant uncontrolled medical conditions, other active inflammatory skin diseases that interfere with assessment, abnormal baseline labs or vital signs, or women who are pregnant or not using required contraception are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, GIA632 could reduce inflammation and itching and improve skin clearance and quality of life for some adults with moderate to severe atopic dermatitis.
How similar studies have performed: Other biologic and small-molecule therapies have shown benefit in moderate to severe atopic dermatitis, but GIA632 is an investigational agent with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Able and willing to sign the informed consent form * Patients with a diagnosis of atopic dermatitis and disease for at least 1 year * Moderate to severe atopic dermatitis Key Exclusion Criteria: * Participants with a clinically significant medical condition or infectious disease (as specified in the protocol) * Participants with any clinically significant abnormal clinical laboratory tests, vital signs, physical examination or ECG * Participant with any other active inflammatory skin disease would interfere with the appropriate assessment of atopic dermatitis in the opinion of the investigator * 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) * Women of childbearing potential unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment. Other protocol-defined inclusion/exclusion criteria may apply.
Where this trial is running
Fremont, California and 27 other locations
- Ctr for Dermatology Clinical Res — Fremont, California, United States (Recruiting)
- Aesthetics Skin Care Dermatologic Surgery — Rockville, Maryland, United States (Recruiting)
- Care Access Hoboken — Hoboken, New Jersey, United States (Recruiting)
- Novartis Investigative Site — Pleven, Bulgaria (Recruiting)
- Novartis Investigative Site — Sofia, Bulgaria (Recruiting)
- Novartis Investigative Site — Sofia, Bulgaria (Recruiting)
- Novartis Investigative Site — Toronto, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Québec, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Ostrava, Poruba, Czechia (Recruiting)
- Novartis Investigative Site — Brno, Czechia (Recruiting)
- Novartis Investigative Site — Prague, Czechia (Recruiting)
- Novartis Investigative Site — Antony, France (Recruiting)
- Novartis Investigative Site — Dijon, France (Recruiting)
- Novartis Investigative Site — Martigues, France (Recruiting)
- Novartis Investigative Site — Nice, France (Recruiting)
- Novartis Investigative Site — Berlin, Germany (Recruiting)
- Novartis Investigative Site — Hamburg, Germany (Recruiting)
- Novartis Investigative Site — Mainz, Germany (Recruiting)
- Novartis Investigative Site — Ipoh, Perak, Malaysia (Recruiting)
- Novartis Investigative Site — George Town, Pulau Pinang, Malaysia (Recruiting)
- Novartis Investigative Site — Kota Kinabalu, Sabah, Malaysia (Recruiting)
- Novartis Investigative Site — Kuala Lumpur, Malaysia (Recruiting)
- Novartis Investigative Site — Gdansk, Poland (Recruiting)
- Novartis Investigative Site — Torun, Poland (Recruiting)
- Novartis Investigative Site — Warsaw, Poland (Recruiting)
- Novartis Investigative Site — Singapore, Singapore (Recruiting)
- Novartis Investigative Site — Singapore, Singapore (Recruiting)
- Novartis Investigative Site — Singapore, Singapore (Recruiting)
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.