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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524316-11-00

Enrollment

126

Registered

2026-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-19

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

Conditions

Primary Progressive Multiple Sclerosis (PPMS)

Brief summary

1. Time to onset of composite confirmed disability progression (cCDP) events, confirmed over at least 12 weeks (12-week cCDP), defined as follows: * 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, OR, * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-Hole Peg Test (9HPT)

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
1. Time to onset of composite confirmed disability progression (cCDP) events, confirmed over at least 12 weeks (12-week cCDP), defined as follows: * 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, OR, * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-Hole Peg Test (9HPT)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: May 20, 2026