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
2 other identifiers
interventional
34
9 countries
28
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2025
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 24, 2025
CompletedStudy Start
First participant enrolled
November 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 6, 2027
May 14, 2026
May 1, 2026
1.5 years
October 22, 2025
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
To assess the efficacy of GIA632 compared to placebo at week 16
Baseline, Week 16
Study Arms (2)
GIA632
EXPERIMENTALActive treatment arm
Placebo
PLACEBO COMPARATORPlacebo treatment arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Ctr for Dermatology Clinical Res
Fremont, California, 95438, United States
Aesthetics Skin Care Dermatologic Surgery
Rockville, Maryland, 20850, United States
Care Access Hoboken
Hoboken, New Jersey, 07030, United States
Novartis Investigative Site
Pleven, 5800, Bulgaria
Novartis Investigative Site
Sofia, 1202, Bulgaria
Novartis Investigative Site
Sofia, 1618, Bulgaria
Novartis Investigative Site
Toronto, Ontario, M5A 3R6, Canada
Novartis Investigative Site
Québec, Quebec, G1W 4R4, Canada
Novartis Investigative Site
Ostrava, Poruba, 708 52, Czechia
Novartis Investigative Site
Brno, 602 00, Czechia
Novartis Investigative Site
Prague, 100 34, Czechia
Novartis Investigative Site
Antony, 92160, France
Novartis Investigative Site
Dijon, 21000, France
Novartis Investigative Site
Martigues, 13500, France
Novartis Investigative Site
Nice, 06000, France
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Hamburg, 20095, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Ipoh, Perak, 30450, Malaysia
Novartis Investigative Site
George Town, Pulau Pinang, 10450, Malaysia
Novartis Investigative Site
Kota Kinabalu, Sabah, 88586, Malaysia
Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site
Gdansk, 80-546, Poland
Novartis Investigative Site
Torun, 87-100, Poland
Novartis Investigative Site
Warsaw, 00-872, Poland
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Singapore, 169608, Singapore
Novartis Investigative Site
Singapore, 308205, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2025
First Posted
October 24, 2025
Study Start
November 10, 2025
Primary Completion (Estimated)
May 17, 2027
Study Completion (Estimated)
September 6, 2027
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.