Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments medi2070, placebo
Phase phase 2
Sponsor AstraZeneca
Collaborator MedImmune Ltd
Start date February 2013
End date May 2014
Trial size 174 participants
Trial identifier NCT01714726, D5170C00001, EudraCT number: 2012-004098-26

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
MEDI2070 iv infusion
medi2070
1 iv infusion on Week 0 and Week 4
(Placebo Comparator)
placebo iv infusion
placebo
1 iv infusion on Week 0 and Week 4
(Experimental)
MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
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

Primary Outcomes

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
time frame: Week 8

Secondary Outcomes

Measure
Crohn's Disease Activity Index (CDAI) remission at Week 8, as defined by a CDAI score of < 150
time frame: Week 8
A reduction of at least 100 points from baseline in Crohn's Disease Activity Index (CDAI) at Week 8
time frame: Week 8
A reduction of at least 70 points from baseline in Crohn's Disease Activity Index (CDAI) at Week 8
time frame: Week 8
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
Change from baseline Crohn's Disease Activity Index (CDAI) at Week 8
time frame: Week 8
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
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
Principal investigator Bruce E Sands, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.