Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01714726
First received: October 24, 2012
Last updated: September 4, 2014
Last verified: September 2014
  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:


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), Week 24 (Visit 10), Week 112 (Visit 32) 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), Week 24 (Visit 10), Week 112(Visit 32) postdose ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: May 2014 (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
Placebo Comparator: 2
placebo iv infusion
Drug: placebo
1 iv infusion on Week 0 and Week 4
Experimental: open-label
MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
Drug: MEDI2070
1 sc injection of every 4 weeks for 100 weeks, starting at Week 12; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period

Detailed Description:

This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 46 Study Locations
Sponsors and Collaborators
AstraZeneca
MedImmune Ltd
Investigators
Study Director: Robert A 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: September 4, 2014
Health Authority: Canada: Health Canada
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: The Italian Medicines Agency
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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014