Trial intelligence / Profile preview

Phase 3 Study of Orelabrutinib in Primary Progressive Multiple Sclerosis

2025-524316-11-00Phase 3Authorised

Sponsor
Zenas BioPharma
Start
Jun 2026
Modality
Small Molecules
Countries
33
01

Overview

Phase 3, randomised, double-blind trial in primary progressive multiple sclerosis (PPMS) comparing Orelabrutinib with Placebo (2 arms). Primary endpoint: Time to onset of 12-week confirmed composite disability progression (cCDP). Planned start Jun 2026; status: authorised.

02

Drugs

orelabrutinib
03

Conditions

primary progressive multiple sclerosis (PPMS)

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