Multiple Sclerosis (MS) Clinical Trials

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Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• Diagnosis of RMS.

• EDSS at screening: 0-5.5, inclusive.

• Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).

⁃ 1\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.

Locations
Other Locations
Poland
TG Therapeutics Investigational Trial Site
RECRUITING
Gdansk
TG Therapeutics Investigational Trial Site
NOT_YET_RECRUITING
Poznan
Contact Information
Primary
TG Therapeutics Clinical Support Team
clinicalsupport@tgtxinc.com
1-877-575-8489
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2033-06-30
Participants
Target number of participants: 240
Treatments
Experimental: Part A: Ublituximab
New Regimen
Experimental: Part B: Ublituximab
New Regimen
Placebo_comparator: Part B: Placebo
Experimental: Part B: Fingolimod
Placebo_comparator: Part B: IV Placebo
Experimental: Part C: OLE
Sponsors
Leads: TG Therapeutics, Inc.

This content was sourced from clinicaltrials.gov