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.
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