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Completed

NCT Number: NCT01959165

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Chikushino-shi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI7183 low dose

Drug

MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8

MEDI7183 medium dose

Drug

MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8

MEDI7183 high dose

Drug

MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8

Matching Placebo

Drug

Placebo will be administered by SC on Day 1, Week 2,4, and 8

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Oct 9, 2013
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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