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Completed

NCT Number: NCT01096862

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Total Skin & Beauty Dermatology Center, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peficitinib

Drug

oral

Other names: ASP015K

Placebo

Drug

oral

Primary outcomes

  1. Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score

    Time frame: 6 weeks

  2. 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

Secondary outcomes

  1. Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)

    Time frame: 6 weeks

  2. Change from baseline to end of treatment in percent body surface area (BSA)

    Time frame: 6 weeks

  3. Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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