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Ulcerative Colitis

Protocol 20110166

 

A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis

This is a randomized, double blind, placebo controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at week 8. After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open label period during which all subjects will receive open label AMG 181at a single dose level according to protocol. Subjects who failed to achieve a response at week 8 and also have an inadequate response at week 12 or after are eligible to enter the open label period of the study early. Subjects who achieved response and/or remission at week 8 and subsequently experience disease worsening are eligible to enter the open label period early ONLY if a confirmatory rectosigmoidoscopy confirms disease severity as defined by protocol. Subjects that complete the open label period or early terminate from the study will enter the 2 year safety follow up period.

 

 

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