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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | lowest dose |
|
| Group 2 | Experimental | low dose |
|
| Group 3 | Experimental | high dose |
|
| Group 4 | Experimental | highest dose |
|
| Group 5 | Experimental | medium dose |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peficitinib | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| Therapeutics Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25704750 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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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/.
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.
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.
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| Placebo | Drug | oral |
|
| Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear |
| 6 weeks |
| 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 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
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