NCT07299019Phase 3Recruiting

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Study sponsor: Zenas BioPharma (USA), LLC

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2030-06Estimated

Enrollment · participants990Estimated

Source updated2026-09-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-03-20 · 1 field changed

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

Check registry source

Posted 2026-01-12 · 1 field changed

Planned enrollment increased by 660 participants

− Before

~~330 participants (planned)~~

+ After

990 participants (planned)

Check registry source

Study details

Conditions studied

Secondary Progressive Multiple Sclerosis

Treatments or interventions studied

OrelabrutinibDrug
PlaceboDrug

Primary outcomes · main study measures

measure: Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks; description: Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0; timeFrame: Up to approximately 120 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history