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Subcutaneous versus intravenous ublituximab for relapsing MS pharmacokinetics and effects

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

PHASE3 · TG Therapeutics, Inc. · NCT07211633

This tests whether giving ublituximab under the skin works similarly to the IV form in people with relapsing multiple sclerosis.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorTG Therapeutics, Inc. (industry)
Drugs / interventionsublituximab
Locations42 sites (Banja Luka and 41 other locations)
Trial IDNCT07211633 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, open-label, parallel-group, multicenter trial comparing subcutaneous (SC) and intravenous (IV) administration of ublituximab in participants with relapsing multiple sclerosis. The study measures pharmacokinetics and pharmacodynamics, along with safety, radiological outcomes, and clinical measures over the treatment period. Eligible participants are neurologically stable adults with relapsing MS and EDSS ≤ 5.5 who have not received prior anti-CD20 therapy. The trial is conducted at multiple TG Therapeutics investigational sites.

Who should consider this trial

Good fit: Adults with relapsing multiple sclerosis who are neurologically stable, have an EDSS score of 5.5 or less, have not previously received anti-CD20 therapy, and (for women of childbearing potential) can use effective contraception are the intended participants.

Not a fit: People with primary‑progressive MS, inactive secondary‑progressive MS, significant immune or bone marrow impairment, or prior anti‑CD20 treatment are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, subcutaneous ublituximab could offer a more convenient and potentially faster administration option with similar effectiveness and safety to IV dosing for people with relapsing MS.

How similar studies have performed: Other anti‑CD20 therapies have demonstrated clear benefit in relapsing MS and a subcutaneous anti‑CD20 (ofatumumab) is already approved, but subcutaneous ublituximab as a route is less well established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Diagnosis of RMS (2017 Revised McDonald criteria).
2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
3. Neurologically stable for \> 30 days prior to Screening and Day 1.
4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.

Exclusion Criteria:

1. Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.

Note: Other Inclusion/Exclusion criteria may apply.

Where this trial is running

Banja Luka and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsing Multiple Sclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.