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A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

Trial Profile

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2026

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At a glance

  • Drugs Orelabrutinib (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms PriMroSe trial
  • Sponsors InnoCare Pharma

Most Recent Events

  • 24 Aug 2026 According to an InnoCare Pharma media release, data from this study has been accepted for presentation at MSToronto 2026.
  • 27 Mar 2026 According to Zenas BioPharma media release, the company will use the net proceeds from the Convertible Notes Offering and the Equity Offering for funding the ongoing and planned orelabrutinib Phase 3 clinical trials for progressive multiple sclerosis.
  • 04 Dec 2025 Planned initiation date changed from 1 Sep 2025 to 1 Dec 2025.

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