MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

NCT01959165 | Completed Phase 2 Results

• 1 other identifier: D5172C00001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 23

Brief 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

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis, Japanese, subcutaneously

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Remission at Week 8

  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 Outcomes (3)

• Number of Participants With Response at Week 8

  8 weeks

• Number of Participants With Mucosal Healing at Week 8

  8 weeks

• Number of Participants With Response at Week 12

  12 weeks

Study Arms (4)

MEDI7183 dose 1

EXPERIMENTAL

Double blinded

Drug: MEDI7183 low dose

MEDI7183 dose 2

EXPERIMENTAL

Double blinded

Drug: MEDI7183 medium dose

MEDI7183 dose 3

EXPERIMENTAL

Double blinded

Drug: MEDI7183 high dose

Placebo

PLACEBO COMPARATOR

Double blinded

Drug: Matching Placebo

Interventions

MEDI7183 low dose DRUG

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

MEDI7183 dose 1

MEDI7183 medium dose DRUG

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

MEDI7183 dose 2

MEDI7183 high dose DRUG

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

MEDI7183 dose 3

Matching Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (23)

Research Site

Chikushino-shi, 818-8502, Japan

Location

Research Site

Fujiidera-shi, 583-0027, Japan

Location

Research Site

Fukuyama-shi, 720-8520, Japan

Location

Research Site

Hamamatsu, 432-8061, Japan

Location

Research Site

Kagoshima, 892-0846, Japan

Location

Research Site

Kamakura-shi, 247-0056, Japan

Location

Research Site

Kyoto, 606-8507, Japan

Location

Research Site

Kyoto, 612-8555, Japan

Location

Research Site

Minatoku, 108-8642, Japan

Location

Research Site

Morioka, 020-8505, Japan

Location

Research Site

Niigata, 950-1104, Japan

Location

Research Site

Nishinomiya-shi, 663-8501, Japan

Location

Research Site

Osaka, 545-8586, Japan

Location

Research Site

Ōita, 870-0033, Japan

Location

Research Site

Sakura-shi, 285-8741, Japan

Location

Research Site

Sapporo, 004-0041, Japan

Location

Research Site

Sapporo, 060-0033, Japan

Location

Research Site

Sapporo, 065-0033, Japan

Location

Research Site

Sayama-shi, 350-1305, Japan

Location

Research Site

Shinagawa-ku, 141-0022, Japan

Location

Research Site

Shinjuku-ku, 169-0073, Japan

Location

Research Site

Yokkaichi-shi, 510-0016, Japan

Location

Research Site

Yokohama, 236-0004, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

abrilumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Nii Masahiro
• Organization: Biometrics

Masahiro.Nii@astrazeneca.com

+81 6 7711 4571

Study Officials

• Toshifumi Hibi, Director and Professor

  Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University

  PRINCIPAL INVESTIGATOR

• Ki Rito, Study Physician

  AztraZeneca, Tokyo, Japan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 9, 2013
• Study Start: November 21, 2013
• Primary Completion: August 11, 2015
• Study Completion: April 10, 2018
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

JP (23)