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ADESOS: Orismilast in moderate to severe atopic dermatitis
NCT05469464Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2022
- Primary completion
- Jan 2024
- Countries
- 4
- Sponsor
- UNION therapeutics
- Modality
- Small Molecules
- Drugs
- orismilast
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, randomised, double-blind trial of orismilast in atopic dermatitis (AD) (4 arms), sponsored by UNION therapeutics. Primary endpoint: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at 16 weeks. Started Jul 2022; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Orismilast 20 mg
Orismilast modified release tablets 20 mg BID
Orismilast 30 mg
Orismilast modified release tablets 30 mg BID
Orismilast 40 mg
Orismilast modified release tablets 40 mg BID
Placebo
Placebo tablets BID
03
Who it enrols
Adults with moderate-to-severe atopic dermatitis diagnosed for at least 1 year who are candidates for systemic treatment, excluding those with therapy-resistant disease or active infections.
04
Endpoints
Primary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score
Secondary
Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI)
Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD
Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score
Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS)
05
Results
Not all primary endpoints met
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