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

NCT ID: NCT01096862

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-23

Study Completion Date

2011-07-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

lowest dose

Group Type EXPERIMENTAL

peficitinib

Intervention Type DRUG

oral

Group 2

low dose

Group Type EXPERIMENTAL

peficitinib

Intervention Type DRUG

oral

Group 3

high dose

Group Type EXPERIMENTAL

peficitinib

Intervention Type DRUG

oral

Group 4

highest dose

Group Type EXPERIMENTAL

peficitinib

Intervention Type DRUG

oral

Group 5

medium dose

Group Type EXPERIMENTAL

peficitinib

Intervention Type DRUG

oral

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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peficitinib

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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ASP015K

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Total Skin & Beauty Dermatology Center

Birmingham, Alabama, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

FXM Research, Corp.

Miami, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Derm Research, PLLC

Louisville, Kentucky, United States

Site Status

Oregon Medical Research Center

Portland, Oregon, United States

Site Status

Palmetto Clinical Trial Services

Greenville, South Carolina, United States

Site Status

Rivergate Dermatology

Goodlettsville, Tennessee, United States

Site Status

J & S Studies

College Station, Texas, United States

Site Status

Virginia Clinical Research

Norfolk, Virginia, United States

Site Status

Madison Skin & Research, Inc

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25704750 (View on PubMed)

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=327

Link to results on the Astellas Clinical Study Results website

Other Identifiers

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015K-CL-PS01

Identifier Type: -

Identifier Source: org_study_id

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