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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

Trial Profile

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 of Trial: Phase II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Olamkicept (Primary)
  • Indications Ulcerative colitis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors I-MAB Biopharma; Leading Biopharm
  • Most Recent Events

    • 30 Dec 2021 Status changed from recruiting to completed.
    • 23 May 2021 Results assessing efficacy and safety of olamkicept, a soluble gp130-Fc fusion protein that inhibits trans-signaling by binding to the IL-6/ soluble IL-6R complex, for induction in active ulcerative colitis (UC). presented at the Digestive Disease Week 2021
    • 26 Apr 2021 According to an I-MAB Biopharma media release, detailed data analysis will be presented at Digestive Disease Week (DDW) 2021 in the U.S. in May and at European Crohn's and Colitis Organisation (ECCO) meeting in July 2021.
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