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Clinical Trials in the EU / 2025-524322-18-00
Ongoing Phase III

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

2025-524322-18-00 · tracked via the Priya Life Science EU tracker
Sponsor
Zenas Biopharma (USA) LLC
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
22/06/2026
Enrollment target
496
Sites
Germany, Bulgaria, Netherlands, Sweden, Portugal, Croatia, Italy, Austria, Spain, Poland, France, Denmark, Hungary, Romania, Estonia, Slovakia, Belgium, Czechia, Norway, Lithuania, Greece, Slovenia

Condition studied

Non-active Secondary Progressive Multiple Sclerosis (SPMS)

Investigational medicinal product(s)

Placebo tablets match with that of orelabrutinib (ICP-022) tablets in appearanceshapesizeand weight.Orelabrutinib

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks (24-week CDP).

Endpoint detail

1) Time to onset of CDP events on EDSS, confirmed over at least 12 weeks (12-week CDP), 2) The total number of new or enlarging T2 lesions on MRI scans of the brain

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524322-18-00 on CTIS ↗ ← All trials in the EU