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New drug hope for kids with MS: ublituximab trial launches

NCT ID NCT07220252

Disease control Sponsor: TG Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests the drug ublituximab in children aged 10 to 18 with relapsing multiple sclerosis (MS). It compares ublituximab to another drug, fingolimod, to see which better controls relapses. The trial involves 240 participants and will also monitor long-term safety and effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ublituximab (a drug given by IV infusion)
What this could lead to
If successful, this could provide a new treatment option for children with relapsing multiple sclerosis to reduce relapses.
What could go wrong
This is an early-to-mid stage trial (Phase 2/3) with 240 participants, so results may not confirm long-term benefit or safety. Risks include infusion reactions and infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Gdansk, 80-952, Poland

  • TG Therapeutics Investigational Trial Site

    NOT_YET_RECRUITING

    Poznan, 60-355, Poland

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Other studies related to the condition(s) this trial covers.