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Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

This study is currently recruiting participants.
Verified February 2013 by AstraZeneca
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01714726
First received: October 24, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period.


Condition Intervention Phase
Crohn's Disease
 Drug: MEDI2070
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Crohn's Disease Activity Index (CDAI) remission at Week 8, as defined by a CDAI score of < 150 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • A reduction of at least 100 points from baseline in Crohn's Disease Activity Index (CDAI) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • A reduction of at least 70 points from baseline in Crohn's Disease Activity Index (CDAI) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index (CDAI) response (either remission defined by CDAI < 150 or a CDAI reduction from baseline of at least 100 points from baseline) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline Crohn's Disease Activity Index (CDAI) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) evaluation of Multiple Doses of MEDI2070 [ Time Frame: Week 0(Visit 3), Week 4 (Visit 5), Week 8 (Visit 6) predose; Week 0(Visit 3), Week 4 (Visit 5) postdose ] [ Designated as safety issue: No ]
  • Immunogenicity (IM) evaluation of Multiple Doses of MEDI2070 [ Time Frame: Week 0(Visit 3), Week 8 (Visit 6) postdose ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI2070 iv infusion
 Drug: MEDI2070
1 iv infusion on Week 0 and Week 4
Drug: placebo
1 iv infusion on Week 0 and Week 4
Placebo Comparator: 2
placebo iv infusion
Experimental: open-label
MEDI2070 sc injection
 Drug: MEDI2070
1 sc injection of every 4 weeks for 100 weeks, starting at Week 12

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714726

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

  Show 47 Study Locations
Sponsors and Collaborators
AstraZeneca
MedImmune Ltd
Investigators
Study Director: Robert Gasser, MD MedImmune, LLC; One MedImmune Way; Gaithersburg, MD 20878; United States
Principal Investigator: Bruce E Sands, MD, MS Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1069, New York, NY 10029
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01714726     History of Changes
Other Study ID Numbers: D5170C00001, EudraCT number: 2012-004098-26
Study First Received: October 24, 2012
Last Updated: February 12, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: General Manager of Coordinator Site
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
MEDI2070
inflammatory bowel disease
moderate to severe Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013