Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis

Active Ulcerative Colitis Clinical Trial

Official title:
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II study.

Clinical Trial Description

is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105. 90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive 600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03235752
Study type	Interventional
Source	I-Mab Biopharma HongKong Limited
Contact
Status	Completed
Phase	Phase 2
Start date	February 6, 2018
Completion date	December 21, 2020

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See also
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