Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatments medi7183 low dose, medi7183 medium dose, medi7183 high dose, matching placebo
Phase phase 2
Sponsor AstraZeneca
Start date November 2013
End date August 2015
Trial size 59 participants
Trial identifier NCT01959165, D5172C00001

Summary

This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Double blinded
medi7183 low dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
(Experimental)
Double blinded
medi7183 medium dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
(Experimental)
Double blinded
medi7183 high dose
MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
(Placebo Comparator)
Double blinded
matching placebo
Placebo will be administered by SC on Day 1, Week 2,4, and 8

Primary Outcomes

Measure
Remission rate
time frame: Week 8

Secondary Outcomes

Measure
Response rate
time frame: Week 8
Mucosal healing rate
time frame: Week 8
Response rate assessed by PMS
time frame: Week 12
Safety and torelability assessed by adverse event rate etc
time frame: 0-76 weeks
Pharmacokinetics assessed by Serum concentration
time frame: 0-76 weeks
Pharmacodynamics assessed by Receptor Occupancy and memory CD4 α4β7 hi cell numbers
time frame: 0-12 weeks
Anti- MEDI7183 antibodies
time frame: 0-76 weeks

Eligibility Criteria

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

Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a histopathology report - Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with rectosigmoidoscopy score ≥ 2 during screening period - Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc. Exclusion Criteria: - Disease limited to the rectum - Toxic megacolon - Crohn's Disease - History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC - Planned bowel surgery within 12 weeks from Visit 2 - Stool positive for C. difficile toxin at screening - Primary Sclerosing Cholangitis - History of gastrointestinal surgery within 8 weeks of Visit 2 - Any uncontrolled or clinically significant systemic disease - Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion - Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc

Additional Information

Principal investigator Toshifumi Hibi, Director and Professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.