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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524322-18-00

Enrollment

177

Registered

2026-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-active Secondary Progressive Multiple Sclerosis (SPMS)

Brief summary

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

Detailed description

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

Interventions

DRUGOrelabrutinib

DRUGPlacebo tablets match with that of orelabrutinib (ICP-022) tablets in appearance

DRUGshape

DRUGsize

DRUGand weight.

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 24, 2026