MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
NCT ID: NCT01959165
Last Updated: 2019-07-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2013-11-21
2018-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
NCT03893565
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT03915769
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
NCT00573469
Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
NCT07271069
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
NCT07229950
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MEDI7183 dose 1
Double blinded
MEDI7183 low dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
MEDI7183 dose 2
Double blinded
MEDI7183 medium dose
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
MEDI7183 dose 3
Double blinded
MEDI7183 high dose
MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
Placebo
Double blinded
Matching Placebo
Placebo will be administered by SC on Day 1, Week 2,4, and 8
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Toshifumi Hibi, Director and Professor
Role: PRINCIPAL_INVESTIGATOR
Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University
Ki Rito, Study Physician
Role: STUDY_DIRECTOR
AztraZeneca, Tokyo, Japan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Chikushino-shi, , Japan
Research Site
Fujiidera-shi, , Japan
Research Site
Fukuyama-shi, , Japan
Research Site
Hamamatsu, , Japan
Research Site
Kagoshima, , Japan
Research Site
Kamakura-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Kyoto, , Japan
Research Site
Minatoku, , Japan
Research Site
Morioka, , Japan
Research Site
Niigata, , Japan
Research Site
Nishinomiya-shi, , Japan
Research Site
Osaka, , Japan
Research Site
Ōita, , Japan
Research Site
Sakura-shi, , Japan
Research Site
Sapporo, , Japan
Research Site
Sapporo, , Japan
Research Site
Sapporo, , Japan
Research Site
Sayama-shi, , Japan
Research Site
Shinagawa-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Yokkaichi-shi, , Japan
Research Site
Yokohama, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D5172C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.