MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959165
• Other study ID #: D5172C00001
• Status: Completed
• Phase: Phase 2
• Start date: November 21, 2013
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 10, 2018
• Est. primary completion date: August 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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-a 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• MEDI7183 low dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
• MEDI7183 medium dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
• MEDI7183 high dose
MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
• Matching Placebo
Placebo will be administered by SC on Day 1, Week 2,4, and 8

Locations

Country	Name	City	State
Japan	Research Site	Chikushino-shi
Japan	Research Site	Fujiidera-shi
Japan	Research Site	Fukuyama-shi
Japan	Research Site	Hamamatsu-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kamakura-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Minato-ku
Japan	Research Site	Morioka-shi
Japan	Research Site	Niigata-shi
Japan	Research Site	Nishinomiya-shi
Japan	Research Site	Oita-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Sakura-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sayama-shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Yokkaichi-shi
Japan	Research Site	Yokohama-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Response at Week 8	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
Secondary	Number of Participants With Mucosal Healing at Week 8	Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.	8 weeks
Secondary	Number of Participants With Response at Week 12	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