Last updated on November 2019

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


Brief description of study

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

Detailed Study 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 biweekly (Q2W), 300mg TJ301 Q2W or placebo Q2W.

Clinical Study Identifier: NCT03235752

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