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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: GIA632; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07220577

CGIA632A12201

Details and patient eligibility

About

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).

Full description

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

GIA632

Experimental group

Description:

Active treatment arm

Treatment:

Drug: GIA632

Placebo

Placebo Comparator group

Description:

Placebo treatment arm

Treatment:

Other: Placebo