RecruitingPhase 2NCT07220577
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants 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
Sponsor
Novartis Pharmaceuticals
Enrollment
84 participants
Start Date
Nov 10, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria3
- 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
Exclusion Criteria6
- 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.
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Interventions
DRUGGIA632
Active treatment arm
OTHERPlacebo
Placebo treatment arm
Locations(28)
View Full Details on ClinicalTrials.gov
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NCT07220577
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