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Active, not recruiting Phase 2

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

NCT07220577 · tracked via the Priya Life Science Poland tracker
Phase
Phase 2
Started
2025-11-10
Last updated
2026-05-14

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

GIA632 →Placebo

GIA632: Active treatment arm

Placebo: Placebo treatment arm

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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 highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • 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

Trial sites (28)

FacilityCityRegionStatus
Ctr for Dermatology Clinical Res Fremont California
Aesthetics Skin Care Dermatologic Surgery Rockville Maryland
Care Access Hoboken Hoboken New Jersey
Novartis Investigative Site Pleven Bulgaria
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Toronto Ontario
Novartis Investigative Site Québec Quebec
Novartis Investigative Site Ostrava Poruba
Novartis Investigative Site Brno Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Antony France
Novartis Investigative Site Dijon France
Novartis Investigative Site Martigues France
Novartis Investigative Site Nice France
Novartis Investigative Site Berlin Germany
Novartis Investigative Site Hamburg Germany
Novartis Investigative Site Mainz Germany
Novartis Investigative Site Ipoh Perak
Novartis Investigative Site George Town Pulau Pinang
Novartis Investigative Site Kota Kinabalu Sabah
Novartis Investigative Site Kuala Lumpur Malaysia
Novartis Investigative Site Gdansk Poland
Novartis Investigative Site Torun Poland
Novartis Investigative Site Warsaw Poland
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Singapore Singapore
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220577 on ClinicalTrials.gov ↗ ← All trials in Poland