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

NCT03235752 ↗

Phase 2 Completed 91 enrolled I-Mab Biopharma HongKong Limited

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2018-02-06
Primary completion: 2020-12-21
Completion: 2020-12-21

Outcome

Mixed primary results

paper with adjusted difference vs placebo of 26.6% (90% CI, 6.2% to 47.1%; P = .03) for 600 mg PMID 36881032 ↗

paper 8.3% (90% CI, -12.6% to 29.1%; P = .52) for 300 mg PMID 36881032 ↗

paper biweekly infusion of olamkicept 600 mg, but not 300 mg, resulted in a greater likelihood of clinical response at 12 weeks compared with placebo. PMID 36881032 ↗

Publications

Zhang S, Chen B, Wang B, Chen H, Li Y, Cao Q, Zhong J, Shieh MJ, Ran Z, Tang T, Yang M, Xu B, Wang Q, Liu Y, Ma L, Wang X, Zhang N, Zhang S, Guo W, Huang L, Schreiber S, Chen M. Effect of Induction Therapy With Olamkicept vs Placebo on Clinical Response in Patients With Active Ulcerative Colitis: A Randomized Clinical Trial. JAMA. 2023 Mar 7;329(9):725-734. doi: 10.1001/jama.2023.1084.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olamkicept	Unknown	300 mg	Intravenous
Subject	Olamkicept	Unknown	600 mg	Intravenous