A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01096862
First received: March 18, 2010
Last updated: July 18, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: ASP015K Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Change from baseline to end of treatment in percent body surface area (BSA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 124 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
lowest dose
|
Drug: ASP015K
oral
|
|
Experimental: Group 2
low dose
|
Drug: ASP015K
oral
|
|
Experimental: Group 3
high dose
|
Drug: ASP015K
oral
|
|
Experimental: Group 4
highest dose
|
Drug: ASP015K
oral
|
|
Experimental: Group 5
medium dose
|
Drug: ASP015K
oral
|
| Placebo Comparator: Placebo |
Drug: Placebo
oral
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096862
Locations
| United States, Alabama | |
| Total Skin & Beauty Dermatology Center | |
| Birmingham, Alabama, United States, 35205 | |
| United States, California | |
| Therapeutics Clinical Research | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| FXM Research, Corp. | |
| Miami, Florida, United States, 33175 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| United States, Kentucky | |
| Derm Research, PLLC | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Oregon | |
| Oregon Medical Research Center | |
| Portland, Oregon, United States, 97223 | |
| United States, South Carolina | |
| Palmetto Clinical Trial Services | |
| Greenville, South Carolina, United States, 29607 | |
| United States, Tennessee | |
| Rivergate Dermatology | |
| Goodlettsville, Tennessee, United States, 37072 | |
| United States, Texas | |
| J & S Studies | |
| College Station, Texas, United States, 77845 | |
| United States, Virginia | |
| Virginia Clinical Research | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Wisconsin | |
| Madison Skin & Research, Inc | |
| Madison, Wisconsin, United States, 53719 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Medical Director | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01096862 History of Changes |
| Other Study ID Numbers: | 015K-CL-PS01 |
| Study First Received: | March 18, 2010 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Psoriasis ASP015K |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013