NCT03235752

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: I-Mab Biopharma HongKong Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	TJ301 300mg	TJ301 300mg IV infusion
DRUG	TJ301 600mg	TJ301 600mg IV infusion
DRUG	Placebo	Placebo IV infusion

Timeline

• Start date: 2018-02-06
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2017-08-01
• Last updated: 2021-01-05

Locations

27 sites across 3 countries: China, South Korea, Taiwan