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Clinical Trials in the EU / 2025-523892-50-00
Ongoing Phase III

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)

2025-523892-50-00 · tracked via the Priya Life Science EU tracker
Sponsor
Region Stockholm – SLSO
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Nervous System Diseases
Decision date
02/06/2026
Enrollment target
60
Sites
Sweden

Condition studied

Multiple Sclerosis

Investigational medicinal product(s)

TolebrutinibRITUXIMAB

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Relative change from baseline in CSF NfL at 12 months

Endpoint detail

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

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 2025-523892-50-00 on CTIS ↗ ← All trials in the EU