Last Update: Nov 14, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CGIA632A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Atopic Dermatitis
Phase2
Recruiting
84
Nov 10, 2025
Sep 13, 2027
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

GIA632

Active treatment arm
Other

Placebo

Placebo treatment arm

Eligibility Criteria

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.

Novartis Investigative Site

Recruiting

Toronto,Ontario,M5a 3r6,Canada

Novartis Investigative Site

Recruiting

Singapore,119074,Singapore

Novartis Investigative Site

Recruiting

Singapore,308205,Singapore

Ctr for Dermatology Clinical Res

Recruiting

Fremont,California,95438,United States

Natalya Likhareva
Sunil Dhawan

Care Access Hoboken

Recruiting

Hoboken,New Jersey,07030,United States

Adolfo Obregon
Sameer Verma

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals