A Randomized Open Label Trial Exploring the Soluble and Imaging Biomarker Dynamic Responses to Tolebrutinib Compared to Rituximab Treatment in Patients with Multiple Sclerosis (MS)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523892-50-00

Enrollment

Registered

2026-06-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-02

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

Conditions

Multiple Sclerosis

Brief summary

Relative change from baseline in CSF NfL at 12 months

Detailed description

Serum NfL at 12 and 24 months, CSF and serum GFAP at 12 and 24 months, CSF biomarkers of chemokines (CXCL10, CXCL13), innate immuny (LCN2, CHIT1), complement system (C1QA, C5), and synapses (SNAP25, SV2A) at 12 months

Interventions

DRUGTolebrutinib

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relative change from baseline in CSF NfL at 12 months	—

Secondary

Measure	Time frame
Serum NfL at 12 and 24 months, CSF and serum GFAP at 12 and 24 months, CSF biomarkers of chemokines (CXCL10, CXCL13), innate immuny (LCN2, CHIT1), complement system (C1QA, C5), and synapses (SNAP25, SV2A) at 12 months	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 3, 2026