Recruiting
Phase 2
Phase 3

Ublituximab & Fingolimod

Sponsor:

TG Therapeutics, Inc.

Code:

NCT07220252

Conditions

Relapsing Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Placebo

Placebo

Fingolimod

Study Details

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 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).

Conditions

Relapsing Multiple Sclerosis

Study ID

NCT07220252

Start date

Jul 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria for Part A and Part B:

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).

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:

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.

Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):

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.

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Ublituximab

New Regimen

experimental: Part B: Ublituximab

New Regimen

placebo comparator: Part B: Placebo

experimental: Part B: Fingolimod

placebo comparator: Part B: IV Placebo

experimental: Part C: OLE

Interventions

Ublituximab

Administered as an intravenous (IV) infusion.

Placebo

Oral capsule.

Placebo

IV infusion.

Fingolimod

Oral capsule.

Primary outcome measure

  • Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab [ Time Frame: Predose and multiple timepoints up to Week 24 ]
  • Part A: Maximum Observed Concentration (Cmax) of Ublituximab [ Time Frame: Day 1 and Day 15 ]
  • Part A: Participant B Cell Counts [ Time Frame: Up to Week 24 ]
  • Part B: Annualized Relapse Rate (ARR) [ Time Frame: Up to 96 weeks ]
  • Part C: Annualized Relapse Rate (ARR) [ Time Frame: Up to 168 weeks ]

Central Contacts and Locations

Central contacts

TG Therapeutics Clinical Support Team

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

Locations

TG Therapeutics Investigational Trial Site

Recruiting

Salt Lake City, Utah, United States, 84113

More Information

Sponsor

TG Therapeutics, Inc.

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by TG Therapeutics, Inc. on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.