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ASP015K in moderate to severe plaque psoriasis
NCT01096862Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2010
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- Astellas Pharma
- Modality
- Small Molecules
- Drugs
- peficitinib
- Conditions
- plaque psoriasis
01
Overview
Phase 2, randomised, double-blind trial of peficitinib in plaque psoriasis (6 arms), sponsored by Astellas Pharma. Primary endpoints: Change from baseline in Psoriasis Area Severity Index at 6 weeks and Safety assessments at 6 weeks. Started Mar 2010; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Lowest Dose
peficitinib (likely 10 mg BID)
Low Dose
peficitinib (likely 25 mg BID)
Medium Dose
peficitinib (likely 50 mg QD)
High Dose
peficitinib (likely 60 mg BID)
Highest Dose
peficitinib (likely 100 mg BID)
Placebo
Matching placebo
03
Who it enrols
Adult patients with moderate to severe plaque psoriasis for at least 6 months with at least 10% BSA affected, who are candidates for phototherapy or systemic therapy. Patients with non-plaque psoriasis, recent systemic therapy, or positive TB test are excluded.
04
Endpoints
Primary
Change from baseline in Psoriasis Area Severity Index
Safety assessments
Secondary
Physicians Static Global Assessment
Percent Body Surface Area
Physician's Static Global Assessment Success
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