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Recruiting Phase 2 NCT07220577

NCT07220577 Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis

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Clinical Trial Summary
NCT ID NCT07220577
Status Recruiting
Phase Phase 2
Sponsor Novartis Pharmaceuticals
Condition Atopic Dermatitis
Study Type INTERVENTIONAL
Enrollment 84 participants
Start Date 2025-11-10
Primary Completion 2027-05-17

Trial Parameters

Condition Atopic Dermatitis
Sponsor Novartis Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 84
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2025-11-10
Completion 2027-05-17
Interventions
GIA632Placebo

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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).

Eligibility 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 hi

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