Status:
TERMINATED
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
Lead Sponsor:
Amgen
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (...
Eligibility Criteria
Inclusion
- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
- Moderately to severely active Crohn's disease, as defined by a CDAI score \>250 and \< 450 at baseline
- Evidence of active inflammation
Exclusion
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 3 months
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
- Ulcerative colitis
- Evidence of an infected abscess
- Bowel perforation or evidence of noninflammatory obstruction during the 6 months
- Stool positive for C. Difficile toxin at screening
- Presence of active infection requiring treatment
- Serious infection within 8 weeks
- Significant concurrent medical conditions
- Pregnant or breast feeding
- Significant Laboratory abnormalities
- Any anti-tumor necrosis factor (TNF) agent within 2 months
- Steroid enemas within 2 weeks
- Tysabri (natalizumab) within 1 year
- Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
- Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months
Key Trial Info
Start Date :
November 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2011
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01150890
Start Date
November 9 2010
End Date
October 15 2011
Last Update
January 3 2022
Active Locations (50)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Dothan, Alabama, United States
3
Research Site
Lowell, Arkansas, United States
4
Research Site
Jacksonville, Florida, United States