Phase 3 Multiple Sclerosis Trial, Recruiting NCT07220252 Sponsor: TG Therapeutics, Inc. Condition: Multiple Sclerosis
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Phase 3 Multiple Sclerosis Trial, Recruiting

NCT07220252
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:

For Parts A and B:

  • People who have been diagnosed with relapsing multiple sclerosis (RMS)
  • People whose disability level falls within a certain range on a standard MS scoring scale (EDSS score between 0 and 5.5) at the time of screening
  • People whose MS symptoms have been stable for at least 30 days before screening, and remain stable between screening and the first day of the trial

For Part C:

  • People who have already completed either Part A (up to Week 24) or Part B (up to Week 96) of this same trial

Who may not be able to join:

For Parts A and B:

  • People who have, or are suspected to have, another neurological condition that could look similar to MS
  • People who have used higher-dose steroid medications (by mouth or injection) within 30 days before their screening MRI scan — note that steroid creams, eye drops, or inhalers are generally allowed (confirm with trial site)
  • People who have received high-dose intravenous or under-the-skin immunoglobulin therapy within 2 months before the trial start date
  • People who have ever been treated with anti-CD20 therapies or other treatments that target B cells (a type of immune cell)
  • People who have ever been treated with alemtuzumab, cladribine, cyclophosphamide, or mitoxantrone (specific MS or immune-suppressing medicines)

For Part B only (additional restrictions related to one of the study medicines):

  • People who have ever been treated with fingolimod or similar medicines that work on a specific part of the immune system (S1P1 modulators)
  • People who are taking a certain category of heart rhythm medicines (Class Ia anti-arrhythmics) at the time of screening

For Part C:

  • People whose lymphocyte count (a measure of certain immune cells in the blood) falls outside a specified range will not be considered eligible to receive the study treatment in Part C (confirm exact range with trial site)

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 19 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
1 July 2026
Est. completion
1 January 2030

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab; Part A: Maximum Observed Concentration (Cmax) of Ublituximab; Part A: Participant B Cell Counts; Part B: Annualized Relapse Rate (ARR); Part C: Annualized Relapse Rate (ARR)

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: 19 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