MedDataX Logo

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

NCT ID: NCT07220577

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2027-09-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, placebo-controlled, parallel-group, non-confirmatory, investigator and participant blinded study in adult participants with moderate to severe AD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phase 2 interventional atopic dermatitis efficacy safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GIA632

Active treatment arm

Group Type EXPERIMENTAL

GIA632

Intervention Type DRUG

Active treatment arm

Placebo

Placebo treatment arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo treatment arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GIA632

Active treatment arm

Intervention Type DRUG

Placebo

Placebo treatment arm

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ctr for Dermatology Clinical Res

Fremont, California, United States

Site Status RECRUITING

Aesthetics Skin Care Dermatologic Surgery

Rockville, Maryland, United States

Site Status RECRUITING

Care Access Hoboken

Hoboken, New Jersey, United States

Site Status RECRUITING

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Singapore

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Evguenia Vals

Role: primary

Jessica Baccouche

Role: primary

Ugonna Igwe

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CGIA632A12201

Identifier Type: -

Identifier Source: org_study_id