Ublituximab
DrugAdministered as an intravenous (IV) infusion.
Other names: TG-1101, BRIUMVI
NCT Number: NCT07220252
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).
Interested in participating?
Request Info10 year–17 year
All sexes
Interventional
Phase 2 / Phase 3
TG Therapeutics Investigational Trial Site, Gdansk, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Part A and Part B:
Inclusion criteria
for Part C:
Exclusion criteria
for Part A and B:
Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
Exclusion criteria
for Part C:
Note: Other protocol-specified inclusion/exclusion criteria may apply
Administered as an intravenous (IV) infusion.
Other names: TG-1101, BRIUMVI
Oral capsule.
Oral capsule.
Time frame: Predose and multiple timepoints up to Week 24
Time frame: Day 1 and Day 15
Time frame: Up to Week 24
Time frame: Up to 96 weeks
Time frame: Up to 168 weeks
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Time frame: Up to Week 24
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Time frame: Up to Week 24
Time frame: Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks
Time frame: Up to Week 96
Time frame: Up to 96 weeks
Time frame: Up to Week 96
Time frame: Up to Week 24
Time frame: Up to Week 24
Contact information is provided by the study sponsor or research team.
TG Therapeutics, Inc.
Industry
Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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