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NCT Number: NCT07220577

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Pleven, Bulgaria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GIA632

Drug

Active treatment arm

Placebo

Other

Placebo treatment arm

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

    Time frame: Baseline, Week 16

    To assess the efficacy of GIA632 compared to placebo at week 16

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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