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NOT_YET_RECRUITINGPHASE2/PHASE3

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

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

NCT07220252•TG Therapeutics, Inc.

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

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of RMS.
•2. EDSS at screening: 0-5.5, inclusive.
•3. 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.

Exclusion Criteria

•1. Known presence or suspicion of other neurologic disorders that may mimic MS.
•2. Prior treatments:
•1. Systemic corticosteroids (\>0.1 milligrams/kilogram/day \[mg/kg/day\], or \>5 milligrams/day \[mg/day\] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted).
•2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
•3. Treatment with anti-CD20 or other B cell directed treatment at any time.
•4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.
•1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
•2. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.
•1\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.

Key Dates

Start Date

March 31, 2026

Primary Completion Date

January 1, 2030

Completion Date

June 30, 2033

Last Updated

February 27, 2026

Enrollment

240

ESTIMATED participants

Conditions

Relapsing Multiple Sclerosis

Interventions

Ublituximab

DRUG

Placebo

DRUG

Placebo

DRUG

Fingolimod

DRUG

Contacts

TG Therapeutics Clinical Support Team

CONTACT

1-877-575-8489 clinicalsupport@tgtxinc.com

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

NCT07426991

Multiple SclerosisRemitting-Relapsing Multiple Sclerosis+4 more

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RECRUITING

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

NCT06433752

Relapsing Multiple SclerosisMultiple Sclerosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

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