A Phase 2, Uncontrolled, Three-Stage, Dose-Escalation Cohort Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Clinical Activity of OMS721 in Adults With Thrombotic Microangiopathies

Trial Profile

A Phase 2, Uncontrolled, Three-Stage, Dose-Escalation Cohort Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Clinical Activity of OMS721 in Adults With Thrombotic Microangiopathies

Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Apr 2018

At a glance

  • Drugs OMS 721 (Primary)
  • Indications Thrombotic microangiopathy
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Omeros Corporation
  • Most Recent Events

    • 26 Apr 2018 The U.S. FDA has granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. Breakthrough therapy designation was granted based on data from this trial.
    • 15 Feb 2018 Results presented in an Omeros Corporation media release.
    • 03 Jan 2018 According to an Omeros Corporation media release, Company intends to amend the ongoing Phase II protocol following discussion with FDA and/or EMA to transition the protocol into a Phase III/pivotal trial. Company intends to submit the full application for breakthrough therapy designation to the FDA, by the end of this month.
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