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A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study with Risankizumab As Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

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Trial Profile

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study with Risankizumab As Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2024

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At a glance

  • Drugs Sonelokimab (Primary) ; Risankizumab
  • Indications Plaque psoriasis; Psoriatic arthritis
  • Focus Therapeutic Use
  • Acronyms IZAR-2
  • Sponsors MoonLake Immunotherapeutics

Most Recent Events

  • 03 Dec 2024 Status changed from not yet recruiting to recruiting.
  • 13 Nov 2024 According to a MoonLake Immunotherapeutics media release, the initiation of this Phase 3 program follows the announcement in June 2024 of the successful outcome of MoonLake's end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the European Medicines Agency (EMA).
  • 13 Nov 2024 According to a MoonLake Immunotherapeutics media release, readout of the primary endpoint is anticipated in H1 2026.

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