A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096862
• Other study ID #: 015K-CL-PS01
• Status: Completed
• Phase: Phase 2
• Start date: March 23, 2010
• Est. completion date: July 27, 2011

Study information

• Verified date: June 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 27, 2011
• Est. primary completion date: July 27, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• peficitinib
oral
• Placebo
oral

Locations

Country	Name	City	State
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	J & S Studies	College Station	Texas
United States	Rivergate Dermatology	Goodlettsville	Tennessee
United States	Palmetto Clinical Trial Services	Greenville	South Carolina
United States	Derm Research, PLLC	Louisville	Kentucky
United States	Madison Skin & Research, Inc	Madison	Wisconsin
United States	FXM Research, Corp.	Miami	Florida
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Oregon Medical Research Center	Portland	Oregon
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score		6 weeks
Primary	Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)		6 weeks
Secondary	Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)		6 weeks
Secondary	Change from baseline to end of treatment in percent body surface area (BSA)		6 weeks
Secondary	Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear		6 weeks

External Links

•   Link to results on the Astellas Clinical Study Results website