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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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