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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
peficitinib
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring ASP015K, Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Total Skin & Beauty Dermatology Center
  • Therapeutics Clinical Research
  • FXM Research, Corp.
  • Renstar Medical Research
  • Derm Research, PLLC
  • Oregon Medical Research Center
  • Palmetto Clinical Trial Services
  • Rivergate Dermatology
  • J & S Studies
  • Virginia Clinical Research
  • Madison Skin & Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Placebo

Arm Description

lowest dose

low dose

high dose

highest dose

medium dose

Matching placebo

Outcomes

Primary Outcome Measures

Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)

Secondary Outcome Measures

Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)
Change from baseline to end of treatment in percent body surface area (BSA)
Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear

Full Information

First Posted
March 18, 2010
Last Updated
June 6, 2019
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01096862
Brief Title
A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2010 (Actual)
Primary Completion Date
July 27, 2011 (Actual)
Study Completion Date
July 27, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
ASP015K, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
lowest dose
Arm Title
Group 2
Arm Type
Experimental
Arm Description
low dose
Arm Title
Group 3
Arm Type
Experimental
Arm Description
high dose
Arm Title
Group 4
Arm Type
Experimental
Arm Description
highest dose
Arm Title
Group 5
Arm Type
Experimental
Arm Description
medium dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
peficitinib
Other Intervention Name(s)
ASP015K
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
Time Frame
6 weeks
Title
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 Outcome Measure Information:
Title
Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)
Time Frame
6 weeks
Title
Change from baseline to end of treatment in percent body surface area (BSA)
Time Frame
6 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
FXM Research, Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Derm Research, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Palmetto Clinical Trial Services
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Rivergate Dermatology
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
J & S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Madison Skin & Research, Inc
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
25704750
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=327
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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