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MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

NCT01959165 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-07-05

Study results available
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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

Interventions

DRUG

MEDI7183 low dose

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

DRUG

MEDI7183 medium dose

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

DRUG

MEDI7183 high dose

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

DRUG

Matching Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Toshifumi Hibi, Director and Professor · Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University

  • Ki Rito, Study Physician · AztraZeneca, Tokyo, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-21
Primary Completion
2015-08-11
Completion
2018-04-10

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959165 on ClinicalTrials.gov