ChariotMS trial of Mavenclad in UK enrolls 100 progressive MS patients

ChariotMS, the world’s first clinical trial to test whether Mavenclad (cladribine) can slow the worsening of upper limb function in people with progressive multiple sclerosis (MS), has now enrolled 100 participants.

The announcement means the Phase 2 trial (NCT04695080) has reached 50% of its target recruitment goal. It is expected to enroll 200 patients with progressive disease, including those with primary progressive (PPMS) or secondary progressive MS (SPMS), whose ability to walk is severely impaired.

“If successful, ChariotMS would be a major step towards a first [disease-modifying therapy] to protect upper limb function for people with MS who aren’t able to use their lower limbs at all or can only walk short distances with help from aids like crutches,” Klaus Schmierer, PhD, study lead investigator from Queen Mary University of London and Barts Health NHS Trust in the U.K., said in a press release.

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People with advanced MS who cannot walk often not eligible for clinical trials

People with advanced MS, who rely on wheelchairs or walking aids to cover even short distances, are not eligible for most MS clinical trials. That’s because walking ability is often a key measure when evaluating the efficacy of investigational disease-modifying therapies (DMTs).

Moreover, inflammation had been thought to play a minor role in advanced MS, but recent evidence suggests DMTs like Mavenclad may help this patient population.

Mavenclad is a short-course oral DMT approved in the U.K. for highly active relapsing forms of MS, including relapsing-remitting MS and active SPMS. It works by reducing the number of immune cells in the bloodstream, particularly B- and T-cells, which are the main drivers of inflammation and disease activity in MS.

“Preserving hand and arm function would unquestionably improve the quality of life of people with MS, helping them to live more independent lives,” said Clare Walton, PhD, head of research at the MS Society in the U.K.

The ongoing ChariotMS trial is enrolling adults with an Expanded Disability Status Scale score from 6.5 to 8.5. This means they are either unable to walk more than 20 meters (about 65 feet) with two crutches or cannot walk at all but still retain some movement in their arms and hands.

Participants will be randomly assigned to receive Mavenclad or placebo tablets in two short treatment courses, one year apart, lasting 8-10 days each, and will be followed for up to two years.

Preserving hand and arm function would unquestionably improve the quality of life of people with MS, helping them to live more independent lives.

The study’s primary goal is to determine if treatment can slow the decline in hand and arm function, as assessed by the Nine Hole Peg Test after two years. Secondary measures include changes in disability levels, lower limb function, cognition, and the treatment’s impact on brain lesions.

“Some 20 years ago there was nothing out there for anyone with MS and no hope for any treatment, but thankfully it’s a different picture now,” said Tina Morris, the hundredth person to join ChariotMS, who was diagnosed with PPMS in 2012. “There are many options for treatments for relapsing MS but at last primary MS is in the limelight.”

There are currently 20 ChariotMS trial centers open across the U.K. Individuals who think they might be eligible for the trial are encouraged to speak with their doctors about a referral, or to email the study team at [email protected].

“We hope that Tina’s story will encourage others to ask their MS specialist about ChariotMS,” Walton said.