ACTRIMS 2026: ULTIMATE trial testing Briumvi in kids with MS to launch soon
ENABLE study now monitoring real-world effects of therapy in adults
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A new clinical trial dubbed ULTIMATE KIDS will test Briumvi for pediatric multiple sclerosis.
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The trial, enrolling soon, targets children with relapsing MS showing recent disease activity.
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Another trial, ENABLE, is monitoring the therapy's real-world effects in adults with MS – the patient population for whom it's approved.
A clinical trial testing TG Therapeutics‘ CD20 inhibitor Briumvi (ublituximab-xiiy) in children with relapsing forms of multiple sclerosis (MS) will begin enrolling participants within the next few months, the developer announced, also unveiling details of the study’s design.
The upcoming Phase 2/3 trial (NCT07220252) will run in two parallel parts. A Phase 2 portion called ULTIMATE KIDS 1 will evaluate a reduced dose of Briumvi in children weighing 25-40 kg (55-88 pounds). Meanwhile, a Phase 3 randomized part dubbed ULTIMATE KIDS 2 will test Briumvi against fingolimod in children and adolescents ages 10-17.
Fingolimod, sold as Gilenya and Tascenso ODT, with generics also available, is now the only MS therapy approved for this younger patient population.
The trial will start enrolling at sites in the U.S. and Poland, but is expected to expand to additional countries at a later date, according to TG. Altogether, it will involve more than 200 pediatric patients who have MS.
The study’s design was presented in a pair of posters at the recent Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026, held last week in San Diego and virtually.
In another TG-sponsored poster at the conference, scientists presented data from the ongoing Phase 4 ENABLE trial (NCT06433752) of Briumvi, which is scheduled to run through 2027. Those updates, the company noted, demonstrate the real-world tolerability of Briumvi infusions among adults with relapsing forms of MS — the patient population for whom the therapy is currently approved in the U.S.
Michael S. Weiss, chairman and CEO of TG, said in a press release that the company was “pleased” to share the data at this year’s ACTRIMS meeting.
“Our presentations reflect our continued focus on advancing the clinical understanding of Briumvi and supporting the MS community with meaningful data,” Weiss said.
ULTIMATE KIDS will test Briumvi in 2 parallel parts
In MS, the immune system mistakenly attacks healthy parts of the nervous system. Briumvi is designed to lower the levels of immune B-cells, which are thought to be key players in these attacks.
The therapy is given via infusions into the bloodstream. After two initial loading doses given two weeks apart, patients receive 450 mg maintenance doses once every six months. Briumvi is approved in the U.S. for adults with relapsing forms of MS, specifically clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
The ULTIMATE KIDS study will now evaluate the therapy’s potential benefits in pediatric MS patients who have relapsing MS and have shown signs of recent disease activity in the form of relapses or brain lesions.
ULTIMATE KIDS 1 will evaluate the safety and pharmacological properties of a modified maintenance dose of Briumvi in children weighing up to about 90 pounds. The design of this part was described in a poster titled “Study Design of a Phase 2 Ublituximab Dose-Confirmation Study in Children and Adolescents with Relapsing Multiple Sclerosis: ULTIMATE KIDS I,”
An estimated 6-12 children will receive an initial loading dose of Briumvi (150 mg), followed by a modified maintenance dose (300 mg) two weeks later. The participants will then be monitored for about six months.
The goal is to determine whether the results of this reduced dose in patients who weigh less — both in levels of Briumvi in the bloodstream and in B-cell levels — are similar to those seen with the approved dose in adults.
The blueprint for ULTIMATE KIDS 2 was described in a poster titled “Study Design of a Phase 3, Randomized, Double-Blind Study of Ublituximab Versus Fingolimod in Children and Adolescents with Relapsing Multiple Sclerosis: ULTIMATE KIDS II.”
This portion is designed to enroll approximately 234 children who will be randomly assigned to receive Briumvi or fingolimod for nearly two years. The main goal is to determine whether Briumvi is as effective as Gilenya at reducing relapse rates.
The study will initially enroll only children who weigh more than 40 kg. Once the safety of the modified dosing regimen is confirmed in ULTIMATE KIDS 1, the trial will also start enrolling children weighing 25-40 kg.
After either study, children may be eligible to enter an open-label extension phase, in which all will receive Briumvi for up to about three more years, or a safety follow-up study.
ENABLE data shows no serious reactions to therapy’s use
In another poster at ACTRIMS, scientists discussed the infusion experiences of participants in ENABLE, an observational study monitoring the real-world effects of Briumvi in adults with relapsing forms of MS. That poster was titled “Real-World Infusion Experience with Ublituximab in ENABLE: the First Phase 4 Observational Study for Patients with Relapsing Multiple Sclerosis Initiating Ublituximab.”
The analysis involved 658 people with an average age of 43. More than a third of participants had never received an MS therapy, while 29% transitioned from another B-cell therapy.
The median duration of the first Briumvi infusion was a little longer than four hours. Subsequent infusions took about an hour — the expected infusion time based on the prescribing label.
Infusion-related reactions were most common with the first infusion, occurring in 18% of participants. This was substantially lower than what was observed in the trials that supported Briumvi’s approval. The researchers noted that the drop may be related to pretreatment with fever-reducing medications that were not used in the earlier studies.
Reactions decreased in frequency for subsequent infusions. For the second through fourth infusions, 7.4% to 10.6% of participants experienced a reaction, the data showed.
All infusion reactions were mild or moderate in severity and resolved completely. None were considered serious, according to the researchers. The most common were headache, nausea, throat irritation, itching, flushing, and fatigue.
“In the real-world setting, [Briumvi] has demonstrated consistent tolerability,” the researchers wrote in the poster.
The Multiple Sclerosis News Today team is providing virtual coverage of the ACTRIMS Forum 2026 from Feb. 5-7. Go here to see the latest stories from the conference.
