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Active, not recruitingNCT07220577Updated May 14, 2026

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

A Phase 2 interventional study of GIA632 and Placebo in Atopic Dermatitis, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 28 sites in 9 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Atopic Dermatitis

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Keywords

  • Phase 2
  • interventional
  • atopic dermatitis
  • efficacy
  • safety
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    GIA632

    Active treatment arm

    Drug: GIA632

  • Placebo comparator
    Placebo

    Placebo treatment arm

    Other: Placebo

Interventions

  • DrugGIA632

    Active treatment arm

  • OtherPlacebo

    Placebo treatment arm

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, Week 16

07

Study locations

28 sites
  • Ctr for Dermatology Clinical Res
    Fremont, California 95438, United States
  • Aesthetics Skin Care Dermatologic Surgery
    Rockville, Maryland 20850, United States
  • Care Access Hoboken
    Hoboken, New Jersey 07030, United States
  • Novartis Investigative Site
    Pleven, 5800, Bulgaria
  • Novartis Investigative Site
    Sofia, 1202, Bulgaria
  • Novartis Investigative Site
    Sofia, 1618, Bulgaria
  • Novartis Investigative Site
    Toronto, Ontario M5A 3R6, Canada
  • Novartis Investigative Site
    Québec, Quebec G1W 4R4, Canada
  • Novartis Investigative Site
    Ostrava, Poruba 708 52, Czechia
  • Novartis Investigative Site
    Brno, 602 00, Czechia
  • Novartis Investigative Site
    Prague, 100 34, Czechia
  • Novartis Investigative Site
    Antony, 92160, France
  • Novartis Investigative Site
    Dijon, 21000, France
  • Novartis Investigative Site
    Martigues, 13500, France
  • Novartis Investigative Site
    Nice, 06000, France
  • Novartis Investigative Site
    Berlin, 10117, Germany
  • Novartis Investigative Site
    Hamburg, 20095, Germany
  • Novartis Investigative Site
    Mainz, 55131, Germany
  • Novartis Investigative Site
    Ipoh, Perak 30450, Malaysia
  • Novartis Investigative Site
    George Town, Pulau Pinang 10450, Malaysia
  • Novartis Investigative Site
    Kota Kinabalu, Sabah 88586, Malaysia
  • Novartis Investigative Site
    Kuala Lumpur, 59100, Malaysia
  • Novartis Investigative Site
    Gdansk, 80-546, Poland
  • Novartis Investigative Site
    Torun, 87-100, Poland
  • Novartis Investigative Site
    Warsaw, 00-872, Poland
  • Novartis Investigative Site
    Singapore, 119074, Singapore
  • Novartis Investigative Site
    Singapore, 169608, Singapore
  • Novartis Investigative Site
    Singapore, 308205, Singapore
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07220577
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 24, 2025
Start date
Nov 10, 2025
Primary completion
May 17, 2027 (estimated)
Completion
Sep 6, 2027 (estimated)
Last update
May 14, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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