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

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: GIA632; Other: Placebo

• Registration Number: NCT07220577
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-22
• Last Update Submitted: 2025-10-22
• Study First Posted: 2025-10-24
• Last Update Posted: 2025-10-24
• Study Start: 2025-11-18
• Primary Completion: 2027-05-24
• Study Completion: 2027-09-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GIA632	GIA632	Active treatment arm
Placebo	Placebo	Placebo treatment arm

Primary Outcome Measures

Name	Time	Method
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline	Baseline, Week 16	To assess the efficacy of GIA632 compared to placebo at week 16