A Phase 2 interventional study of Ublituximab and Ublituximab in Multiple Sclerosis, sponsored by TG Therapeutics, Inc.. Recruiting at 44 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by TG Therapeutics, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 350 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.
Drug: Ublituximab
Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.
Drug: Ublituximab · Device: Prefilled pen
Administered as an SC injection by a syringe.
Also known as: TG-1101
Administered as an SC injection by prefilled pen.
Also known as: TG-1101
Ublituximab will be administered as an SC injection by prefilled pen.
Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
Time frame: Up to Week 12
Part 1: Plasma Concentrations of Ublituximab
Time frame: Up to Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 120
Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)
Time frame: Up to Week 96
Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab
Time frame: pre-dose and at multiple timepoints post-dose up to Week 120
Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab
Time frame: pre-dose and at multiple timepoints post-dose up to Week 120
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ublituximab