Clinical Trial

A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

Recruiting
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Summary
The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2024-05-23; most recent amendment 2026-07-16.
Status change: Not Yet Recruiting → Recruiting 2024-07-02
Trial Details
NCT Number NCT06433765
Lead Sponsor TG Therapeutics, Inc.
Conditions Multiple Sclerosis
Enrollment 728 participants
Start Date 2024-06-01
Primary Completion 2035-03-31 (estimated)
Study Completion 2035-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-17