A Multicentre, Randomised, Double-blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis

EMD Serono39 sites in 2 countries854 target enrollmentSeptember 2004

ConditionsArthritis, Psoriatic

InterventionsOnercept Placebo

DrugsOnercept Placebo

Overview

Phase: Phase 3
Intervention: Onercept
Conditions: Arthritis, Psoriatic
Sponsor: EMD Serono
Enrollment: 854
Locations: 39
Primary Endpoint: Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

June 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EMD Serono

Eligibility Criteria

Inclusion Criteria

•Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
•At least 18 years of age
•Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
•Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or
•Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day
•A pregnancy test is not required if the subject is post-menopausal or surgically sterile)
•An out-patient status at the time of enrollment
•Plaque psoriasis for at least 12 months
•Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more
•Candidate for phototherapy or systemic therapy

Exclusion Criteria

•Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
•Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation \[CD\]4, interleukin \[IL\]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
•Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
•Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
•Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
•Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1
•Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1
•Phototherapy within 28 days before Study Day 1
•Use of tanning booths within 14 days before Study Day 1
•Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilbert's syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values

Arms & Interventions

Onercept

Intervention: Onercept

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12(Week 12)
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score(Baseline up to Week 48)
Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score(Baseline up to Week 12)
Mean percentage improvement in the itching scale(Baseline up to Week 12)
Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12(Baseline and Week 12)
Median time to relapse(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(Week 52)
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52(Baseline up to Week 52)
Mean Psoriatic Area and Severity Index (PASI) score(Week 36 up to Week 52)