A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
18 Years
65 Years
Both
Crohn's Disease
Trial Information
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate
to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis
Factor-alpha Therapy
Inclusion Criteria:
- Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
- Men or women age 18 - 65 years at the time of screening.
- Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity
Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.
- No known history of active tuberculosis (TB).
- Received at least one anti-TNFα agent for the treatment of CD and did not initially
respond.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Presence of ileostomy and/or colostomy.
- Short bowel syndrome.
- Bowel perforation or obstruction.
- History of cancer.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The primary endpoint of the study is Crohn's Disease Activity Index (CDAI) response at Week 8, defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points
Outcome Time Frame:
Week 8
Safety Issue:
No
Principal Investigator
Robert Gasser, MD
Investigator Role:
Study Director
Investigator Affiliation:
MedImmune, LLC; One MedImmune Way; Gaithersburg, MD 20878; United States
Authority:
Canada: Canadian Institutes of Health Research
Study ID:
D5170C00001
NCT ID:
NCT01714726
Start Date:
February 2013
Completion Date:
December 2016
Related Keywords:
- Crohn's Disease
- MEDI2070
- inflammatory bowel disease
- moderate to severe Crohn's disease
- Crohn Disease
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Boulder, Colorado |
| Research Site | Boca Raton, Florida |
| Research Site | Albany, Georgia |
| Research Site | Arlington Heights, Illinois |
| Research Site | Baltimore, Maryland |
| Research Site | Battle Kreek, Michigan |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
