MS Trial Alert: Investigators Recruiting for Two Phase 3 Trials of Experimental Evobrutinib in Relapsing MS

SUMMARY: Investigators in the U.S. and abroad are recruiting a total of 1860 people with relapsing forms of MS for two separate studies comparing investigational oral evobrutinib with Aubagio® (teriflunomide, Sanofi Genzyme). The studies – also called evolutionRMS1 and evolutionRMS2 – are sponsored by EMD Serono.DETAILSRationale: Evobrutinib is a different approach from existing, approved MS disease-modifying therapies. It inhibits an enzyme called “Bruton’s tyrosine kinase,” reducing the activation of B cells, which are immune cells that play a role in the response that affects the brain and spinal cord in MS. Evobrutinib also penetrates the brain and spinal cord and may inhibit immune cells in the brain called microglia, which have been linked to MS progression. Evobrutinib is one of several so-called “BTK inhibitors” being tested in the MS pipeline.  Eligibility and Details: Participants should be 18 to 55 years old, and diagnosed with relapsing forms of MS, which include relapsing-remitting disease and active secondary progressive disease (with relapses).  Other criteria may apply.In both studies, participants will be randomly assigned to twice daily treatment with evobrutinib and a placebo matching Aubagio, or once daily treatment with Aubagio and a placebo matching evobrutinib, for a treatment duration of 96 weeks. All participants who complete the 96-week Treatment Period will be offered participation in an Open-Label Extension Period of the study, which is expected to last approximately 144 weeks, followed by a 4-week Safety Follow-up Period. All participants will receive evobrutinib during the Open-Label Extension Period. The primary outcome of both studies will compare how treatment affects the annual rate of relapses. Secondary outcomes include disability worsening, disease activity on MRI scans, physical function, fatigue, and safety.What Else is Involved? The study involves up to in-person visits each to the study site. Visits will involve MRI scans, blood draws, clinical exams, and responding to questionnaires.Please note: This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19.To learn more about the enrollment criteria for these studies, and to find out if you are eligible to participate, please call 1-888-275-7376, or email [email protected].  In the U.S., sites are enrolling in the following cities:

Mobile, AlabamaPhoenix, ArizonaScottsdale, ArizonaTucson, ArizonaHanford, CaliforniaLong Beach, CaliforniaPanorama City, CaliforniaPasadena, CaliforniaSan Diego, CaliforniaWest Hollywood, CaliforniaFort Collins, ColoradoStamford, ConnecticutAltamonte Springs, FloridaDelray Beach, FloridaJacksonville, FloridaNaples, FloridaOrlando, FloridaOrmond Beach, FloridaPort Charlotte, FloridaSarasota, FloridaTallahassee, FloridaTampa, FloridaVero Beach, FloridaWeeki Wachee, FloridaWest Palm Beach, FloridaHonolulu, HawaiiElk Grove Village, IllinoisEvanston, IllinoisLake Barrington, IllinoisNorthbrook, IllinoisFort Wayne, IndianaIndianapolis, IndianaLafayette, IndianaOverland Park, Kansas

Baton Rouge, LouisianaScarborough, MaineBaltimore, MarylandBoston, MassachusettsWorcester, MassachusettsDetroit, MichiganSaint Louis, MissouriTown and Country, MissouriOmaha, NebraskaLas Vegas, NevadaAudubon, New JerseyAmherst, New YorkNew York, New YorkRiverhead, New YorkAsheville, North CarolinaRaleigh, North CarolinaCanton, OhioColumbus, OhioDayton, OhioToledo, OhioSpringfield, OregonAbington, PennsylvaniaFranklin, TennesseeKnoxville, TennesseeFort Wayne, TexasHouston, TexasLubbock, TexasRound Rock, TexasSan Antonio, TexasAlexandria, VirginiaNorfolk, VirginiaVirginia Beach, Virginia

 Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

INFORMATION SHOWING ABOVE WAS PROVIDED BY THE NATIONAL MS SOCIETY, HERE