A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Plaque Psoriasis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 124
- Locations
- 11
- Primary Endpoint
- Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Study Overview
Brief Summary
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.
Detailed Description
Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has moderate to severe plaque psoriasis for 6 months or longer with at least 10% Body Surface Area (BSA) affected
- •Subject must be a candidate for phototherapy and/or systemic therapy
Exclusion Criteria
- •Subject has non-plaque psoriasis or drug-induced psoriasis
- •Subject is on systemic psoriasis therapy within 56 days or 5 half-lives, whichever is longer, prior to first dose of study drug
- •Subject has a positive TB skin test within 3 months of screening or at screening
- •Subject has an abnormal chest x-ray
Arms & Interventions
Group 2
low dose
Intervention: peficitinib (Drug)
Group 1
lowest dose
Intervention: peficitinib (Drug)
Group 3
high dose
Intervention: peficitinib (Drug)
Group 4
highest dose
Intervention: peficitinib (Drug)
Group 5
medium dose
Intervention: peficitinib (Drug)
Placebo
Matching placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time Frame: 6 weeks
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
Time Frame: 6 weeks
Secondary Outcomes
- Change from baseline to end of treatment in percent body surface area (BSA)(6 weeks)
- Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)(6 weeks)
- Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear(6 weeks)