MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

April 16, 2019 updated by: AstraZeneca
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chikushino-shi, Japan, 818-8502
        • Research Site
      • Fujiidera-shi, Japan, 583-0027
        • Research Site
      • Fukuyama-shi, Japan, 720-8520
        • Research Site
      • Hamamatsu-shi, Japan, 432-8061
        • Research Site
      • Kagoshima-shi, Japan, 892-0846
        • Research Site
      • Kamakura-shi, Japan, 247-0056
        • Research Site
      • Kyoto-shi, Japan, 606-8507
        • Research Site
      • Kyoto-shi, Japan, 612-8555
        • Research Site
      • Minato-ku, Japan, 108-8642
        • Research Site
      • Morioka-shi, Japan, 020-8505
        • Research Site
      • Niigata-shi, Japan, 950-1104
        • Research Site
      • Nishinomiya-shi, Japan, 663-8501
        • Research Site
      • Oita-shi, Japan, 870-0033
        • Research Site
      • Osaka-shi, Japan, 545-8586
        • Research Site
      • Sakura-shi, Japan, 285-8741
        • Research Site
      • Sapporo-shi, Japan, 060-0033
        • Research Site
      • Sapporo-shi, Japan, 004-0041
        • Research Site
      • Sapporo-shi, Japan, 065-0033
        • Research Site
      • Sayama-shi, Japan, 350-1305
        • Research Site
      • Shinagawa-ku, Japan, 141-0022
        • Research Site
      • Shinjuku-ku, Japan, 169-0073
        • Research Site
      • Yokkaichi-shi, Japan, 510-0016
        • Research Site
      • Yokohama-shi, Japan, 236-0004
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MEDI7183 dose 1
Double blinded
Drug: MEDI7183 low dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
EXPERIMENTAL: MEDI7183 dose 2
Double blinded
Drug: MEDI7183 medium dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
EXPERIMENTAL: MEDI7183 dose 3
Double blinded
Drug: MEDI7183 high dose
MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
PLACEBO_COMPARATOR: Placebo
Double blinded
Drug: Matching Placebo
Placebo will be administered by SC on Day 1, Week 2,4, and 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Remission at Week 8
Time Frame: 8 weeks
Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Response at Week 8
Time Frame: 8 weeks
Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1.
8 weeks
Number of Participants With Mucosal Healing at Week 8
Time Frame: 8 weeks
Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
8 weeks
Number of Participants With Response at Week 12
Time Frame: 12 weeks
Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Toshifumi Hibi, Director and Professor, Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University
  • Study Director: Ki Rito, Study Physician, AztraZeneca, Tokyo, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2013

Primary Completion (ACTUAL)

August 11, 2015

Study Completion (ACTUAL)

April 10, 2018

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (ESTIMATE)

October 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5172C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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