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A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 25 Mar 2025

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At a glance

  • Drugs Ivarmacitinib (Primary)
  • Indications Ankylosing spondylitis
  • Focus Therapeutic Use
  • Sponsors Jiangsu Hengrui Medicine Co.

Most Recent Events

  • 24 Mar 2025 According to Hengrui Pharmaceutical media release, company received the "Drug Registration Certificate" issued by the State Drug Administration, approving the company Class 1 innovative drug, Ivarmacitinib Sulfate Tablets (trade name: Asuda) for the marketing of adult patients with active ankylosing spondylitis (AS) who are ineffective or intolerant to one or more TNF inhibitors. The approval is based on SHR0302-302 study.
  • 15 Jun 2024 Primary endpoint has been met (Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12) , according to Results presented at the 25th Annual Congress of the European League Against Rheumatism
  • 15 Jun 2024 Results presented at the 25th Annual Congress of the European League Against Rheumatism

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