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
Inclusion
- 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
Exclusion
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