clinical trials

Investigators are looking for people with progressive forms of multiple sclerosis (MS) to participate in two Phase 3 clinical trials assessing the safety and effectiveness of tolebrutinib (SAR442168), an oral BTK inhibitor that is being investigated as a potential treatment, the National Multiple Sclerosis Society announced…

Adults with mild to moderate multiple sclerosis (MS) are being urged to participate in a new clinical trial — STEP for MS — that will assess the impact of two different exercise programs on patients’ mobility, walking abilities, and quality of life. Funded by the Patient-Centered Outcomes Research…

Lesser or stable disability over two years was evident in most progressive multiple sclerosis (MS) patients given a stem cell treatment in a small Phase 1 clinical trial, supporting a larger study now underway, researchers report. These results suggest that a treatment using mesenchymal stem…

Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies — dubbed GEMINI 1 and GEMINI 2 — will…

Ublituximab, an investigational anti-CD20 antibody, outperformed Aubagio (teriflunomide) in lowering the frequency of relapses among people with active, relapsing forms of multiple sclerosis (MS), according to top-line data from the Phase 3 ULTIMATE trials. Full results, including data on safety and secondary goals, are expected to be presented…

Adults with multiple sclerosis (MS) are being urged to enroll in a new clinical trial — now recruiting in Washington and Michigan states — that aims to assess the effectiveness of different treatments to counteract the effects of chronic fatigue. The investigators are hopeful that data from this…

Despite having more severe first and second relapses, children with relapsing-remitting multiple sclerosis (RRMS) tend to recover better than adults with the disease, according to a study. Better recovery in children may be linked to the activation of genes that, in turn, impair the activation of immune cells driving…

Autologous hematopoietic stem cell transplant (AHSCT) induces a reduction in relapse rate and physical disability in patients with relapsing-remitting multiple sclerosis (RRMS) who respond inadequately to other treatments, a small study suggests. The study, “Selective cognitive dysfunction and physical disability improvement after autologous hematopoietic stem cell transplantation…

Treatment with NG-01 — an approach that uses patients’ own mesenchymal stem cells (MSCs) — safely and effectively delayed disease progression in people with active, progressive multiple sclerosis (MS), according to final data from a Phase 2 clinical trial. Delivering these cells directly into the cerebrospinal fluid (CSF)…

Tysabri Affects Immune System Beyond Known MS Target, Study Finds Tysabri (natalizumab) slows multiple sclerosis progression by blocking some immune cells from entering the central nervous system, where they attack the myelin coating of nerves. Yet this study shows that Tysabri may also significantly reduce the number of proteins…

A new $100-million program aims to improve the diversity of participants in U.S. clinical trials with the ultimate goal of achieving better health outcomes and parity in care for underserved patient populations. The initiative seeks to extend the reach of clinical studies to underserved populations in the nation’s urban and rural…

An upcoming Phase 2 clinical trial, called ChariotMS, will test whether Mavenclad (cladribine) can slow a worsening of hand and arm function in people with progressive multiple sclerosis (MS) and very limited walking abilities. Patients reliant on wheelchairs or aids to walk even short distances generally have…

The nonprofit Autoimmune Registry (ARI) has published its first comprehensive list of autoimmune diseases, with information addressing more than 150 disorders, their subtypes, and prevalence in the U.S. This list was created in part to provide patients and scientists easy access to the latest peer-reviewed research, information on clinical…

A non-invasive retina imaging technique known as optical coherence tomography (OCT) provided evidence of the neuroprotective effect of ibudilast (MN-166) — an oral medication designed to reduce the body’s inflammatory responses —  in people with progressive forms of multiple sclerosis (MS). The data also…

Immunic Therapeutics is seeking 60 more adults with relapsing-remitting multiple sclerosis (RRMS) to test a lower dose of IMU-838, its leading oral experimental therapy, in its ongoing Phase 2 EMPhASIS trial. The decision was based on previous trial results showing that both doses tested (30 and 45 mg…

The use of disease-modifying therapies (DMTs) in adults with multiple sclerosis (MS) increased the risk of precancerous growth in those older than 45 years of age, according to an age-related adverse events analysis of several dozen clinical trials. …

Adults with active relapsing-remitting multiple sclerosis (RRMS) treated with Tysabri (natalizumab) had fewer new and accumulated lesions, and a lower relapse rate than those treated with Gilenya (fingolimod) for 24 weeks, according to…

A Phase 3 trial is underway in the U.S. to assess the safety and efficacy of Sativex (nabiximols), an oral spray that contains cannabis extracts, in treating spasticity — muscle stiffness or spasms — associated with multiple sclerosis (MS). Sativex, by…

InnoCare Pharma is preparing to launch a Phase 2 trial to assess the safety and efficacy of orelabrutinib, its investigational Bruton tyrosine kinase inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, which is expected to enroll approximately 160 patients, will be carried out in the U.S.

Adults with multiple sclerosis (MS) and other neurological disorders are being recruited to take part in a 12-week clinical trial that aims to assess the health benefits of home-based tele-exercise — performed while seated — led by the Burke Neurological Institute, in New York, according to an…

MD1003, MedDay Pharmaceuticals’ high-dose biotin therapy, failed to significantly improve functional ability or walking speed in people with non-active progressive multiple sclerosis (MS), according to data from a Phase 3 clinical trial. Besides failing to meet the trial’s goals, the therapy was associated with inaccurate results in…

Biogen is discontinuing the clinical development of opicinumab, its experimental treatment candidate for multiple sclerosis (MS), based on data from the Phase 2 AFFINITY clinical trial. The announcement, amid a third-quarter report, indicated that the study failed to meet both its main and secondary goals, without further details. The trial,…

MS Prevalence at Over 2.8 Million Worldwide, Update to Atlas Reports With almost 3 million of us around the world, we’re not really rare, but we’re rare enough that our MS is still a puzzle to many. People seem to know what muscular dystrophy is (probably because of the…

The U.S. Food and Drug Administration (FDA) has accepted an investigational new drug application (IND) for ANK-700, a treatment candidate for multiple sclerosis (MS) that is being developed by the Swiss company Anokion. With this approval, Anokion can enter clinical testing and is planning to…

AB Science’s lead candidate masitinib safely and effectively delays disability progression in people with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive MS (SPMS), according to top-line data from a clinical trial. The therapy was found to significantly lower the risk of first and confirmed (three-month) disability progression, and to reduce…

Roche has launched a Phase 3 clinical trial program to evaluate fenebrutinib, its investigational oral BTK inhibitor, in people with relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS). Data on fenebrutinib’s potency and selectivity, as well as the design of the clinical…

Novartis is not planning to open a clinical trial of Kesimpta (ofatumumab) as a potential treatment for primary progressive multiple sclerosis (PPMS) anytime soon, a company executive said. But it is well aware of the “unmet need” for therapy options among this patient group, and is exploring avenues. “We do…

Upcoming and ongoing clinical trials aim to expand an understanding of Kesimpta (ofatumumab), the Novartis therapy recently approved by the U.S. Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis (MS). Kesimpta is an anti-CD20 monoclonal antibody, a type of treatment that is thought to work…

Janssen Pharmaceuticals’ investigational oral therapy ponesimod is superior to Sanofi’s Aubagio (teriflunomide) in delaying disability progression in adults with relapsing multiple sclerosis (MS), according to exploratory analyses of OPTIMUM clinical trial data. These and other findings from Janssen’s MS research program, including on the health…

Switching to Genentech’s Ocrevus (ocrelizumab) following suboptimal treatment responses significantly lessens symptoms and leads to high rates of no evidence of disease activity in people with relapsing-remitting multiple sclerosis (RRMS), according to data from a Phase 3b clinical trial. That finding, as well as data about patients’ adherence and…