Terminated/Withdrawn
Sponsor ID
20090072
AMG 827 in Subjects with Moderate to Severe Crohn’s Disease
Study Details
The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate to severe Crohn’s disease. Patients will randomly receive either AMG 827 or placebo (a lookalike liquid that doesn’t have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
Protocol Summary
Primary Outcome Measures
To evaluate the efficacy of AMG 827 compared with placebo as measured by the proportion of subjects achieving Crohn’s Disease Activity Index (CDAI) remission (≤ 150) at week 6.
Timeframe: 6 Weeks
Secondary Outcome Measures
To evaluate the efficacy of AMG 827 as measured by the proportion of subjects with a CDAI response (reduction from baseline of ≥ 100) at week 6
Timeframe: 6 Weeks
To evaluate improvement from baseline in CDAI at week 6
Timeframe: 6 Weeks
To evaluate the short term safety profile of AMG 827 in subjects with Crohn’s disease
Timeframe: 12 Weeks
To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn’s disease
Timeframe: 6 Weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Pontevedra, Galicia, Spain
Status
Recruiting
Location
Research Site
Santiago de Compostela, Galicia, Spain
Status
Recruiting
Location
Research Site
Madrid, Madrid, Spain
Status
Recruiting
Location
Research Site
Birmingham, Alabama, United States
Status
Recruiting
Location
Research Site
Dithan, Alabama, United States
Status
Recruiting
Location
Research Site
Lowell, Arkansas, United States
Status
Recruiting
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