drugset / Trial / NCT00090129

Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis

NCT00090129 ↗

Phase 3 Terminated 854 enrolled EMD Serono
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-09
Primary completion
2005-06
Completion
2005-06

Outcome

Outcome not reported

Stopped: “The risk-benefit ratio for the use of onercept in this condition was not sufficiently favorable to justify continued development”

Drugs

EvaluationDrugModalityDoseRoute
Subject Onercept Protein / enzyme biologic 150 mg Subcutaneous

Indications