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Crohn's Disease

Protocol 20110232


AMG 181 in Subjects With Moderate to Severe Crohn's Disease.


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 (CDAI score < 150) 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. At the end of the double blind period, subjects will enter an open-label period during which all subjects will receive open-label AMG 181 at a single dose level according to protocol. Subjects who fail to achieve minimal improvement, or experience disease worsening after initial response are eligible to enter the open-label period early beginning at week 12 or after. 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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