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A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis

Trial Profile

A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis

Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Feb 2019

At a glance

  • Drugs Mavrilimumab (Primary) ; Prednisone
  • Indications Giant cell arteritis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Kiniksa Pharmaceuticals
  • Most Recent Events

    • 31 Jan 2019 Status changed from suspended to recruiting.
    • 06 Dec 2018 According to a Kiniksa Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) requested additional information regarding the delivery device to be used in this study. In light of its device-related information request, the FDA has placed the company's recently-submitted IND on clinical hold.
    • 06 Dec 2018 Status changed from recruiting to suspended, according to a Kiniksa Pharmaceuticals media release.
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