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A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis

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Trial Profile

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Innovent Biologics
  • Most Recent Events

    • 09 Oct 2020 According to an Innovent Biologics media release, SULINNO (adalimumab injection), has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis in China.
    • 26 Aug 2020 According to an Innovent Biologics media release, the company expects to receive NDA approval in China for IBI-303 in the second half of 2020.
    • 30 Aug 2019 According to an Innovent Biologics media release, results of this study were published in The Lancet Rheumatology journal.
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