Status:
NOT_YET_RECRUITING
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
PHASE3
Brief 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 eq...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Part A and Part B:
- 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).
- Inclusion Criteria for Part C:
- 1\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.
- Exclusion Criteria for Part A and B:
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- 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.
- Exclusion Criteria for Part C:
- 1\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.
- Note: Other protocol-specified inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2033
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07220252
Start Date
December 1 2025
End Date
June 30 2033
Last Update
October 23 2025
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