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Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial With Tadekinig Alfa (r-hIL-18BP) in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency

Trial Profile

Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial With Tadekinig Alfa (r-hIL-18BP) in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs Tadekinig alfa (Primary)
  • Indications Autoimmune disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors AB2 Bio
  • Most Recent Events

    • 21 Mar 2019 According to an AB2 Bio media release, the FDA has approved an IND under which this trial protocol has been amended in the U.S. to include a single-arm open label (SAOL) design with a randomized withdrawal phase for this trial. All the patients will be initially treated with Tadekinig alfa.
    • 23 Jan 2019 Planned End Date changed from 1 Dec 2019 to 1 Jul 2020.
    • 23 Jan 2019 Planned primary completion date changed from 1 May 2019 to 1 Nov 2019.
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