Status:

RECRUITING

Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Atopic Dermatitis

Eligibility:

All Genders

18-100 years

Phase:

PHASE2

Brief Summary

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD. ...

Eligibility Criteria

Key Inclusion Criteria of the master protocol:

  • Able and willing to sign the informed consent (IC)
  • Patients with a diagnosis of AD and onset of disease for at least 1 year
  • Moderate to severe AD

Key Exclusion Criteria of the master protocol:

  • Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)
  • Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG
  • Participant with any other active inflammatory skin disease
  • 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)

Additional inclusion and exclusion criteria may apply depending on the intervention specific requirements

Key Trial Info

Start Date :

May 16 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 22 2028

Estimated Enrollment :

224 Patients enrolled

Trial Details

Trial ID

NCT06947993

Start Date

May 16 2025

End Date

December 22 2028

Last Update

December 22 2025

Active Locations (99)

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Page 1 of 25 (99 locations)

1

Novartis Investigative Site

Birmingham, Alabama, United States, 35233

2

Novartis Investigative Site

Birmingham, Alabama, United States, 35244

3

Novartis Investigative Site

Fort Smith, Arkansas, United States, 72916

4

Novartis Investigative Site

Fountain Valley, California, United States, 92708