Phase 3 clinical trial

The experimental BTK inhibitor evobrutinib was no better than Aubagio (teriflunomide) at preventing relapses, reducing brain lesions, or slowing disability progression in people with relapsing forms of multiple sclerosis (MS), according to data from two Phase 3 trials. Both medications had generally similar safety profiles, although increases…

Bolstered by Phase 2 trial data showing that frexalimab safely reduces the number of brain lesions in people with relapsing forms of multiple sclerosis (MS), developer Sanofi has launched a pair of Phase 3 studies that will test the investigational therapy in relapsing and progressive MS. One of…

The U.S. Food and Drug Administration (FDA) has placed a partial hold on Genentech’s ongoing Phase 3 clinical trials testing fenebrutinib for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS). The decision was based on two cases of patients who experienced elevations in their…

The Phase 3 EVOLUTION clinical trials have failed to demonstrate that evobrutinib is more effective than the approved medication Aubagio (teriflunomide) at preventing disease flares in people with relapsing types of multiple sclerosis (MS). The findings, which were shared by the drug’s developer Merck KGaA (known…

A new under-the-skin formulation of Ocrevus (ocrelizumab) — administered in 10 minutes — is at least as effective as the approved intravenous, or into-the-vein, formulation among people with multiple sclerosis (MS), according to new clinical trial data. Most people given either the new subcutaneous formulation or the intravenous…

Aubagio (teriflunomide) can significantly reduce the risk of developing multiple sclerosis (MS) among adults with signs of MS-like brain damage who don’t yet have any disease symptoms, according to findings from a clinical trial. The results were presented earlier this year at the American Academy of Neurology…

A new formulation of Ocrevus (ocrelizumab), given as a 10-minute under-the-skin injection, was comparable to the approved intravenous version of the therapy in people with multiple sclerosis (MS), according to top-line results from a Phase 3 clinical trial. The medication’s developer, Roche, is planning to submit data from…

A high-dose vitamin D supplement did not reduce the risk of relapses in people with relapsing-remitting multiple sclerosis (RRMS) already using a disease-modifying therapy to control disease activity, according to findings of a Phase 3 clinical trial. The VIDAMS study (NCT01490502) — standing for Vitamin D…

PB006, a biosimilar to Biogen’s approved treatment Tysabri (natalizumab), showed similar safety and efficacy as the original medication in people with relapsing-remitting MS (RRMS), according to data from a Phase 3 clinical trial. “The Antelope trial reported equivalence between [PB006 and Tysabri] treatment across efficacy, safety, and secondary…

The U.S. Food and Drug Administration (FDA) has cleared AB Science to initiate a Phase 3 clinical trial of its investigational treatment masitinib in people with progressive forms of multiple sclerosis (MS). The decision follows approvals in several European countries that will also host trial sites, including…

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Phase 3 trials testing the investigational therapy tolebrutinib in people with multiple sclerosis (MS) and myasthenia gravis based on reports of medication-induced liver injury. Under the clinical hold, new enrollment at U.S. sites…

Dysport (abobotulinumtoxinA), a form of purified botulinum toxin, has received a positive opinion in Europe for managing urinary incontinence in adults with neurogenic detrusor overactivity (NDO), or overactive bladder. The opinion is specifically for those who experience bladder issues due to multiple sclerosis (MS) or spinal cord…

Mapi Pharma, supported by an additional $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate. The study (NCT04121221), which opened in October 2019,…

Richard Burt, MD, the chief of Northwestern Medicine’s immunotherapy for autoimmune diseases division, is taking a sabbatical, and the stem cell program he has headed for many years, which treated a number of people with MS, is shutting down. Burt headed a Phase 3 clinical trial…

MedDay SAS recently announced that it has raised €34 million, about $38.5 million, in a Series B financing round. The money will enable the company to lead a confirmatory Phase 3 clinical trial, called SPI2, in the United States to assess its lead candidate, MD1003, as a treatment for progressive multiple sclerosis (MS). MedDay concluded…