Clinical trial NCT01959165: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, Japanese, subcutaneously
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Remission at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants With Response at Week 8
timeFrame: 8 weeks
measure: Number of Participants With Mucosal Healing at Week 8
timeFrame: 8 weeks
measure: Number of Participants With Response at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chikushino-shi
country: Japan
facility: Research Site
city: Fujiidera-shi
country: Japan
facility: Research Site
city: Fukuyama-shi
country: Japan
facility: Research Site
city: Hamamatsu-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kamakura-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Minato-ku
country: Japan
facility: Research Site
city: Morioka-shi
country: Japan
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Nishinomiya-shi
country: Japan
facility: Research Site
city: Oita-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Sakura-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sayama-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Yokkaichi-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
Study officials:
affiliation: Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University
name: Toshifumi Hibi, Director and Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AztraZeneca, Tokyo, Japan
name: Ki Rito, Study Physician
role: STUDY_DIRECTOR
References: