Status:
RECRUITING
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult participants with moderate to severe atopic dermatitis (AD).
Detailed Description
This is a randomized, placebo-controlled, parallel-group, non-confirmatory, investigator and participant blinded study in adult participants with moderate to severe AD.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 13 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07220577
Start Date
November 10 2025
End Date
September 13 2027
Last Update
December 24 2025
Active Locations (7)
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1
Ctr for Dermatology Clinical Res
Fremont, California, United States, 95438
2
Aesthetics Skin Care Dermatologic Surgery
Rockville, Maryland, United States, 20850
3
Care Access Hoboken
Hoboken, New Jersey, United States, 07030
4
Novartis Investigative Site
Toronto, Ontario, Canada, M5A 3R6