Phase 2a Study to Assess the Efficacy,Safety and Tolerabi... | NCT07220577

ID	Type	Description	Link
2025-521503-43	Other Identifier	EU CTIS

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2025Actual

Primary Completion Date

May 17, 2027Estimated

Completion Date

Sep 6, 2027Estimated

First Submitted Date

Oct 22, 2025

First Submission Date that Met QC Criteria

Oct 22, 2025

First Posted Date

Oct 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GIA632	Experimental	Active treatment arm	Drug: GIA632
Placebo	Placebo Comparator	Placebo treatment arm	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GIA632	Drug	Active treatment arm	GIA632
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ctr for Dermatology Clinical Res		Fremont	California	95438	United States
Aesthetics Skin Care Dermatologic Surgery

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases