Enrollment complete in Phase 3 trial of at-home Briumvi injection for MS

Patient enrollment is complete in a Phase 3 trial testing a new formulation of Briumvi (ublituximab-xiiy), TG Therapeutics‘ multiple sclerosis (MS) medication for relapsing forms of the disease, that could be injected at home.

The new formulation is designed to be given under the skin, or subcutaneously, every two or three months, which could offer a more convenient option than the approved intravenous (into-the-vein) infusion, which is administered by a healthcare provider every six months.

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The ongoing clinical trial (NCT07211633) is assessing whether the subcutaneous version is at least as good as the intravenous one in adults with relapsing forms of MS. The study is evaluating whether the subcutaneous version achieves similar exposure to the medication by week 24, while also assessing safety, efficacy, and other pharmacological properties.

“The completion of enrollment in our Phase 3 subcutaneous Briumvi trial represents a significant step forward for our development program,” Michael S. Weiss, TG Therapeutics’ chairman and CEO, said in a company press release. “We believe subcutaneous Briumvi has the potential to significantly broaden our reach by offering patients greater flexibility, including a self-administered at-home option.”

Top-line data is expected by the end of this year or early next year.

“We thank the investigators, site personnel, and importantly the study participants who are living with MS who made this milestone possible … and we look forward to sharing topline data from this trial around year end 2026 or early 2027,” Weiss added.

B-cells play a key role in driving MS disease activity

MS is caused by the immune system mistakenly attacking the brain and spinal cord, and immune B-cells are known to play a key role in driving these autoimmune attacks.

Briumvi is an antibody-based therapy designed to decrease the number of B-cells and reduce MS inflammation. It works by targeting the CD20 protein on the surface of B-cells.

The medication was approved based on clinical trials showing it significantly reduces relapse rates and the formation of active inflammatory lesions, as well as new or enlarging lesions. Longer-term studies have also suggested it may help slow disability progression.

As currently approved, Briumvi is given as two initial infusions two weeks apart — the first lasting about four hours and the second about one hour — followed by one-hour maintenance infusions every six months.

Study compares at-home injection with standard IV regimen

The ongoing Phase 3 trial enrolled about 360 participants, who were randomly assigned to three groups: two of those groups received subcutaneous Briumvi either every eight weeks or every 12 weeks, and the third received the standard intravenous regimen.

The primary goal is to assess whether the subcutaneous formulation leads to similar exposure to the medication by week 24, compared with the approved dosing schedule.

Secondary outcomes include pharmacological measures, such as drug concentration and how quickly the medication reaches peak levels, along with side effects and efficacy measures such as B-cell counts and changes in lesion number.

TG is also conducting the Phase 3b ENHANCE trial (NCT05877963) to test a modified regimen of intravenous Briumvi. In this trial, the company is evaluating whether the initial two infusions can be combined and whether subsequent infusions can be shortened to 30 minutes.