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EVOLUTION Trials Testing Evobrutinib Now Recruiting

EVOLUTION Trials Testing Evobrutinib Now Recruiting
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Two global Phase 3 clinical trials testing the investigational oral medication evobrutinib are recruiting participants with relapsing forms of multiple sclerosis (MS).

The two identically-designed trials — EVOLUTION RMS 1 (NCT04338022) and EVOLUTION RMS 2 (NCT04338061) — are specifically recruiting people with MS ages 18 to 55.

Collectively, the trials intend to recruit 1,860 people with relapsing types of MS, specifically relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

The trials are recruiting at locations around the world. A full list of U.S. locations for both trials is available at the National Multiple Sclerosis Society website; full location lists and contact details are available at the respective links.

Participants in the studies will need to make in-person visits to study sites. Precautions are being taken to help keep participants safe during in-person visits in the context of the COVID-19 pandemic.

Evobrutinib is an investigational oral MS therapy that is being developed by Merck KGaA (known as EMD Serono in the U.S. and Canada). The medication works by blocking the activity of a protein called Bruton’s tyrosine kinase (BTK), which is involved in the activation of immune cells, most notably B-cells.

By blocking BTK, evobrutinib is intended to reduce immune activity, thus reducing the inflammation that causes damage to the nervous system (the brain and spinal cord) in MS.  Evobrutinib is one of several BTK-inhibiting medications that are being tested in MS.

The EVOLUTION trials are comparing the safety and effectiveness of evobrutinib to that of Sanofi‘s Aubagio (teriflunomide), an approved treatment for MS. Like evobrutinib, Aubagio works by reducing immune activity, albeit through different biological mechanisms.

Participants in the EVOLUTION trials will be assigned randomly to treatment with either evobrutinib (taken twice daily) or Aubagio for 96 weeks (almost two years). Participants also will be given a placebo matching whichever medication they are not assigned to take during this time. Then, for an additional 12 weeks, all participants will be treated with evobrutinib.

These trials’ primary endpoint — the main measurement used to assess effectiveness — is the effect of treatment on annual relapse rates. Disability worsening, disease activity on MRI scans, physical function, fatigue, and safety also will be assessed.

The EVOLUTION trials are sponsored by Merck Healthcare KGaA, an affiliate of Merck KGaA.

Merck announced positive results from a Phase 2 extension trial of evobrutinib last year, which indicated that treatment with the investigational therapy reduced relapse rates in people with relapsing MS.

Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
Total Posts: 1,055
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
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