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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs Tadekinig alfa (Primary)
  • Indications Haemophagocytic lymphohistiocytosis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB2 Bio

Most Recent Events

  • 27 Jan 2025 According to an AB2 Bio media release, AB2 Bio has signed a U.S. option and licensing agreement giving exclusive right to Nippon Shinyaku for commercializing Tadekinig alfa for its lead indication, Primary Monogenic IL-18 driven Hyperinflammatory Syndrome in patients with NLRC4 mutation and XIAP deficiency, in the U.S. (including Guam, Puerto Rico and U.S. Virgin Islands). AB2 Bio retains rights for all other indications in the U.S. territory and all indications in the rest of the world.
  • 27 Jan 2025 According to an AB2 Bio media release, the company continues to prepare Biologics License Application (BLA) and seek marketing authorization for the U.S.
  • 01 Feb 2024 Status changed from active, no longer recruiting to completed.

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