The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
854
Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Time frame: Week 12
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Time frame: Week 52
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Time frame: Week 12
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Time frame: Baseline up to Week 12
Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Time frame: Baseline up to Week 12
Mean percentage improvement in the itching scale
Time frame: Baseline up to Week 12
Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Time frame: Baseline and Week 12
Median time to relapse
Time frame: Week 12 up to Week 36
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Time frame: Week 52
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
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Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
Little Rock, Arkansas, United States
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Fresno, California, United States
University of California, Irvine
Irvine, California, United States
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La Jolla, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Vallejo, California, United States
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Vista, California, United States
Colorado Medical Research Center
Denver, Colorado, United States
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Denver, Colorado, United States
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Time frame: Baseline up to Week 48
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Time frame: Baseline up to Week 52
Mean Psoriatic Area and Severity Index (PASI) score
Time frame: Week 36 up to Week 52