A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
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
1 other identifier
interventional
124
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2010
CompletedStudy Start
First participant enrolled
March 23, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2011
CompletedOctober 21, 2024
October 1, 2024
1.3 years
March 18, 2010
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
6 weeks
Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
6 weeks
Secondary Outcomes (3)
Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)
6 weeks
Change from baseline to end of treatment in percent body surface area (BSA)
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
Study Arms (6)
Group 1
EXPERIMENTALlowest dose
Group 2
EXPERIMENTALlow dose
Group 3
EXPERIMENTALhigh dose
Group 4
EXPERIMENTALhighest dose
Group 5
EXPERIMENTALmedium dose
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
FXM Research, Corp.
Miami, Florida, 33175, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Derm Research, PLLC
Louisville, Kentucky, 40217, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Palmetto Clinical Trial Services
Greenville, South Carolina, 29607, United States
Rivergate Dermatology
Goodlettsville, Tennessee, 37072, United States
J & S Studies
College Station, Texas, 77845, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
Madison Skin & Research, Inc
Madison, Wisconsin, 53719, United States
Related Publications (1)
Papp K, Pariser D, Catlin M, Wierz G, Ball G, Akinlade B, Zeiher B, Krueger JG. A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis. Br J Dermatol. 2015 Sep;173(3):767-76. doi: 10.1111/bjd.13745. Epub 2015 Jun 19.
PMID: 25704750DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 31, 2010
Study Start
March 23, 2010
Primary Completion
July 27, 2011
Study Completion
July 27, 2011
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.