Phase 3 Multiple Sclerosis Trial, Recruiting NCT05877963 Sponsor: TG Therapeutics, Inc. Condition: Multiple Sclerosis
Back to Multiple Sclerosis

Phase 3 Multiple Sclerosis Trial, Recruiting

NCT05877963
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with relapsing multiple sclerosis (MS), based on specific diagnostic guidelines from 2017.
  • You have either never been treated for MS before, or you have previously taken an MS medication but stopped it before joining and have waited long enough since stopping.
  • Your level of physical disability, as measured by a standard MS scale, is at or below a certain moderate level (confirm with trial site).
  • Your MS symptoms have been stable for more than 30 days before starting the study drug.
  • If you are a woman who could become pregnant, you must agree to use an effective form of birth control from the start of the study until 6 months after your last dose of the study drug.
  • (For one part of the study only) You are currently being treated with a specific type of MS medication called an anti-CD20 therapy, have been on it for at least 6 months, and stopped it because it did not work well enough for you or caused problems.

Who may not be able to join:

  • You have previously had a severe allergic or infusion reaction to an anti-CD20 type of medication.
  • You have a type of MS that is primary-progressive, or a form of secondary progressive MS that is no longer active.
  • You have another ongoing condition where your immune system attacks your body (such as rheumatoid arthritis, Crohn's disease, or similar conditions), or you have an immune deficiency condition.
  • You have a serious ongoing or long-term infection (such as tuberculosis, a long-term urinary tract infection, or active hepatitis C) that requires long-term treatment.
  • You have previously had a serious or unusual type of infection (confirm with trial site).
  • You have a current or past hepatitis B infection, or an active hepatitis C infection (some exceptions may apply — confirm with trial site).
  • You have ever shown signs, or there is suspicion, of a serious brain infection called PML (progressive multifocal leukoencephalopathy).
  • You have received a live vaccine (such as for chickenpox or measles) within the 4 weeks before starting the study drug.
  • You have needed a treatment called IVIG for low antibody levels in the 12 months before joining the study.
  • You currently have or have recently had a cancer, other than certain fully treated minor skin cancers.
  • You have ever been treated with any of the following medications: ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab — for any reason.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-877-575-8489

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
TG Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
13 June 2023
Est. completion
1 December 2027

Where this trial is recruiting

🇵🇱 Poland 🇺🇸 United States

Primary endpoints

Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48; Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov