RecruitingPhase 2NCT07220577

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


Sponsor

Novartis Pharmaceuticals

Enrollment

84 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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

Exclusion Criteria6

  • 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.

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Interventions

DRUGGIA632

Active treatment arm

OTHERPlacebo

Placebo treatment arm


Locations(28)

Ctr for Dermatology Clinical Res

Fremont, California, United States

Aesthetics Skin Care Dermatologic Surgery

Rockville, Maryland, United States

Care Access Hoboken

Hoboken, New Jersey, United States

Novartis Investigative Site

Pleven, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Ostrava, Poruba, Czechia

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Antony, France

Novartis Investigative Site

Dijon, France

Novartis Investigative Site

Martigues, France

Novartis Investigative Site

Nice, France

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Ipoh, Perak, Malaysia

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Novartis Investigative Site

Kota Kinabalu, Sabah, Malaysia

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Gdansk, Poland

Novartis Investigative Site

Torun, Poland

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

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NCT07220577


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