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ME3183 in moderate to severe plaque psoriasis
NCT05268016Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2022
- Primary completion
- May 2023
- Countries
- 2
- Sponsor
- Meiji Pharma USA
- Modality
- Small Molecules
- Drugs
- morcamilast
- Conditions
- plaque psoriasis
01
Overview
Phase 2, randomised, double-blind trial of morcamilast in plaque psoriasis (5 arms), sponsored by Meiji Pharma USA. Primary endpoint: Proportion of participants achieving >=75% reduction in PASI at 16 weeks. Started Mar 2022; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
ME3183 5 mg BID
ME3183 5 mg twice daily
ME3183 10 mg QD
ME3183 10 mg once daily
ME3183 7.5 mg BID
ME3183 7.5 mg twice daily
ME3183 15 mg QD
ME3183 15 mg once daily
Placebo
Placebo
03
Who it enrols
Adults with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration. Excludes patients with active infections, malignancy, or recent use of biologics/systemic treatments.
04
Endpoints
Primary
Proportion of participants achieving >=75% reduction in PASI
Secondary
Treatment-Emergent Adverse Events
Percent Change From Baseline in PASI Score
Proportion of participants achieving >=50% reduction in PASI
Proportion of participants achieving >=90% reduction in PASI
Proportion of participants achieving 100% reduction in PASI
Time to PASI-50 and PASI-75
Static Physicians Global Assessment Response
Change From Baseline in Affected Body Surface Area
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