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NCT07220252RecruitingPhase 2/3

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)

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
240 (estimated)
First submitted
22 Oct 2025
Start date
1 Jul 2026
Primary completion date
1 Jan 2030
Lead sponsor
TG Therapeutics, Inc.
NCT number
NCT07220252
EU CT number
2025-522257-19-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 240
  • From 1 Jul 2026 to the primary completion date, 1 Jan 2030
  • 9 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatments:
    • 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).
    • High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
    • Treatment with anti-CD20 or other B cell directed treatment at any time.
    • Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.
    • Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
  • Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
  • The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.

Other illness

  • Known presence or suspicion of other neurologic disorders that may mimic MS.

Lab values

  • 1\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.

Other

  • Note: Other protocol-specified inclusion/exclusion criteria may apply

Who the study is looking for

  • 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.

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandRecruiting
Instytut Centrum Zdrowia Matki Polki
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie
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RzeszówPolandRecruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandRecruiting
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
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WarsawPolandRecruiting
Narodny ustav detskych chorob
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BratislavaSlovakiaRecruiting
TG Therapeutics Investigational Trial Site
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Salt Lake CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.