NCT07220577Active, not recruitingPhase 2
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
Novartis Pharmaceuticals31 sites in 9 countries34 target enrollmentStarted: November 10, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 34
- Locations
- 31
- Primary Endpoint
- IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
GIA632
Experimental
Active treatment arm
Intervention: GIA632 (Drug)
Placebo
Placebo Comparator
Placebo treatment arm
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
Time Frame: Baseline, Week 16
To assess the efficacy of GIA632 compared to placebo at week 16
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (31)
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