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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Crohn's Disease

Thank you

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-TNF╬▒ 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