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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07220577

Enrollment

Registered

2025-10-24

Start date

2025-11-10

Completion date

2027-09-06

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Phase 2, interventional, atopic dermatitis, efficacy, safety

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).

Detailed description

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

Interventions

DRUGGIA632

Active treatment arm

OTHERPlacebo

Placebo treatment arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Bulgaria, Canada, Czechia, France, Germany, Malaysia, Poland, Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026