Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis (FREXALT)

April 9, 2026 updated by: Sanofi

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.

Study details include:

This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration.
The study intervention duration will vary similarly as the study duration.
The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

Study Overview

Status

Recruiting

Conditions

Multiple Sclerosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Trial Transparency email recommended (Toll free number for US & Canada)
Phone Number: option 6 800-633-1610
Email: contact-us@sanofi.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1425
    - Active, not recruiting
    - Investigational Site Number : 0320001
  - Buenos Aires, Argentina, 1023
    - Active, not recruiting
    - Investigational Site Number : 0320008
  - Buenos Aires, Argentina, 1012
    - Active, not recruiting
    - Investigational Site Number : 0320002
  - Buenos Aires, Argentina, 1055
    - Active, not recruiting
    - Investigational Site Number : 0321010
  - Buenos Aires, Argentina, 1060
    - Active, not recruiting
    - Investigational Site Number : 0320009
  - Córdoba, Argentina, 5004
    - Active, not recruiting
    - Investigational Site Number : 0321011
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Active, not recruiting
    - Investigational Site Number : 0320003
Austria
- - Innsbruck, Austria, 6020
    - Recruiting
    - Investigational Site Number : 0400001
  - Linz, Austria, 4020
    - Recruiting
    - Investigational Site Number : 0401002
  - Vienna, Austria, 1180
    - Recruiting
    - Investigational Site Number : 0401003
Belgium
- - Ghent, Belgium, 9000
    - Recruiting
    - Investigational Site Number : 0560006
  - Overpelt, Belgium, 3900
    - Active, not recruiting
    - Investigational Site Number : 0560005
Brazil
- - São Paulo, Brazil, 04515-000
    - Recruiting
    - Jordy Sinapse- Site Number : 0761004
  - São Paulo, Brazil, 04038-002
    - Recruiting
    - PSEG Centro de Pesquisa Clínica- Site Number : 0761021
  - São Paulo, Brazil, 01228-000
    - Recruiting
    - CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0761002
  - São Paulo, Brazil, 01228-200
    - Recruiting
    - Centro de Pesquisas Clínicas - São Paulo- Site Number : 0761027
- Espírito Santo
  - Vitória, Espírito Santo, Brazil, 29055-450
    - Recruiting
    - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0761029
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 41820-020
    - Recruiting
    - Centro de Pesquisas da Clínica IBIS- Site Number : 0761030
  - Salvador, Estado de Bahia, Brazil, 41823-010
    - Recruiting
    - Clinica AMO- Site Number : 0761017
- Federal District
  - Brasília, Federal District, Brazil, 70200-730
    - Recruiting
    - L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
- Goiás
  - Goiânia, Goiás, Brazil, 74605-020
    - Recruiting
    - Universidade Federal de Goias- Site Number : 0761024
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30150-320
    - Recruiting
    - Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0761025
- Paraná
  - Curitiba, Paraná, Brazil, 81210-310
    - Recruiting
    - Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0761001
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
    - Recruiting
    - Hospital Moinhos de Vento- Site Number : 0761005
  - Porto Alegre, Rio Grande do Sul, Brazil, 90110-000
    - Recruiting
    - IMV Pesquisa Neurológica- Site Number : 0761031
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    - Recruiting
    - InsCer - Instituto do Cérebro da PUCRS- Site Number : 0761009
  - Porto Alegre, Rio Grande do Sul, Brazil, 90480-020
    - Recruiting
    - Instituto Ceos- Site Number : 0761028
- Santa Catarina
  - Joinville, Santa Catarina, Brazil, 89202-165
    - Recruiting
    - Clínica Neurológica- Site Number : 0761007
- São Paulo
  - Santo André, São Paulo, Brazil, 09030-010
    - Recruiting
    - Hospital E Maternidade Christovão Da Gama- Site Number : 0761022
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - Recruiting
    - Investigational Site Number : 1000009
  - Panagyurishte, Bulgaria, 4500
    - Recruiting
    - Investigational Site Number : 1001008
  - Pazardzhik, Bulgaria, 4400
    - Recruiting
    - Investigational Site Number : 1000007
  - Pleven, Bulgaria, 5800
    - Recruiting
    - Investigational Site Number : 1000002
  - Pleven, Bulgaria, 5800
    - Recruiting
    - Investigational Site Number : 1001010
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Investigational Site Number : 1000004
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Investigational Site Number : 1000005
  - Sofia, Bulgaria, 1606
    - Recruiting
    - Investigational Site Number : 1001006
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Investigational Site Number : 1001001
  - Sofia, Bulgaria, 1700
    - Recruiting
    - Investigational Site Number : 1000012
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - Recruiting
    - Investigational Site Number : 1240017
- British Columbia
  - Vancouver, British Columbia, Canada, V6T 1Z4
    - Recruiting
    - Investigational Site Number : 1240010
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - Recruiting
    - Investigational Site Number : 1240014
  - Ottawa, Ontario, Canada, K1H 8L6
    - Active, not recruiting
    - Investigational Site Number : 1240002
- Quebec
  - Gatineau, Quebec, Canada, J8Y 1W2
    - Recruiting
    - Investigational Site Number : 1240001
  - Granby, Quebec, Canada, J2G 1T7
    - Recruiting
    - Investigational Site Number : 1240004
  - Lévis, Quebec, Canada, G6W 0M5
    - Recruiting
    - Investigational Site Number : 1240008
  - Québec, Quebec, Canada, G1J 1Z4
    - Recruiting
    - Investigational Site Number : 1240003
Chile
- Reg Metropolitana de Santiago
  - Las Condes, Reg Metropolitana de Santiago, Chile, 7550000
    - Recruiting
    - Investigational Site Number : 1521005
  - Santiago, Reg Metropolitana de Santiago, Chile, 8320325
    - Recruiting
    - Investigational Site Number : 1520002
  - Santiago, Reg Metropolitana de Santiago, Chile, 8330032
    - Recruiting
    - Investigational Site Number : 1520004
  - Santiago, Reg Metropolitana de Santiago, Chile, 8380456
    - Recruiting
    - Investigational Site Number : 1521001
  - Santiago, Reg Metropolitana de Santiago, Chile, 8431657
    - Recruiting
    - Investigational Site Number : 1521003
China
- - Beijing, China, 100034
    - Recruiting
    - Investigational Site Number : 1560005
  - Beijing, China, 100005
    - Recruiting
    - Investigational Site Number : 1560007
  - Beijing, China, 100050
    - Recruiting
    - Investigational Site Number : 1560008
  - Changchun, China, 130021
    - Recruiting
    - Investigational Site Number : 1560003
  - Changsha, China, 410008
    - Active, not recruiting
    - Investigational Site Number : 1560011
  - Chengdu, China, 610041
    - Recruiting
    - Investigational Site Number : 1560004
  - Chengdu, China, 610072
    - Recruiting
    - Investigational Site Number : 1561029
  - Chongqing, China, 400016
    - Recruiting
    - Investigational Site Number : 1560015
  - Dongguan, China, 523000
    - Recruiting
    - Investigational Site Number : 1560020
  - Fuzhou, China, 350001
    - Recruiting
    - Investigational Site Number : 1561028
  - Guangzhou, China, 510630
    - Recruiting
    - Investigational Site Number : 1560002
  - Guangzhou, China, 510180
    - Recruiting
    - Investigational Site Number : 1561026
  - Hangzhou, China, 310003
    - Recruiting
    - Investigational Site Number : 1561023
  - Harbin, China, 150001
    - Recruiting
    - Investigational Site Number : 1561027
  - Hohhot, China, 010050
    - Active, not recruiting
    - Investigational Site Number : 1560019
  - Hohhot, China, 010070
    - Active, not recruiting
    - Investigational Site Number : 1560040
  - Jiazhuang, China, 050000
    - Recruiting
    - Investigational Site Number : 1560010
  - Jinan, China, 250014
    - Recruiting
    - Investigational Site Number : 1561025
  - Nanjing, China, 210008
    - Active, not recruiting
    - Investigational Site Number : 1560018
  - Shanghai, China, 200040
    - Active, not recruiting
    - Investigational Site Number : 1560001
  - Shanghai, China, 200127
    - Recruiting
    - Investigational Site Number : 1560043
  - Shenyang, China, 110004
    - Recruiting
    - Investigational Site Number : 1560014
  - Suzhou, China, 215006
    - Recruiting
    - Investigational Site Number : 1560030
  - Taiyuan, China, 030001
    - Recruiting
    - Investigational Site Number : 1560006
  - Tianjin, China, 300052
    - Recruiting
    - Investigational Site Number : 1560012
  - Wenzhou, China, 325035
    - Active, not recruiting
    - Investigational Site Number : 1560016
  - Wuhan, China, 430030
    - Recruiting
    - Investigational Site Number : 1560009
  - Xi'an, China, 710038
    - Recruiting
    - Investigational Site Number : 1560013
  - Yinchuan, China, 750004
    - Recruiting
    - Investigational Site Number : 1560021
Croatia
- - Zagreb, Croatia, 10000
    - Recruiting
    - Investigational Site Number : 1911001
Czechia
- - Brno, Czechia, 656 91
    - Active, not recruiting
    - Investigational Site Number : 2030005
  - Brno, Czechia, 625 00
    - Active, not recruiting
    - Investigational Site Number : 2031011
  - Hradec Králové, Czechia, 500 05
    - Active, not recruiting
    - Investigational Site Number : 2030002
  - Jihlava, Czechia, 586 01
    - Active, not recruiting
    - Investigational Site Number : 2030006
  - Ostrava, Czechia, 708 52
    - Active, not recruiting
    - Investigational Site Number : 2031007
  - Pardubice, Czechia, 532 03
    - Active, not recruiting
    - Investigational Site Number : 2030010
  - Prague, Czechia, 100 34
    - Active, not recruiting
    - Investigational Site Number : 2031003
  - Prague, Czechia, 150 06
    - Active, not recruiting
    - Investigational Site Number : 2031008
  - Prague, Czechia, 128 08
    - Active, not recruiting
    - Investigational Site Number : 2031004
  - Teplice, Czechia, 415 01
    - Active, not recruiting
    - Investigational Site Number : 2031009
  - Zlín, Czechia, 762 75
    - Active, not recruiting
    - Investigational Site Number : 2030001
Denmark
- - Esbjerg, Denmark, 6700
    - Active, not recruiting
    - Investigational Site Number : 2081002
  - Glostrup Municipality, Denmark, 2600
    - Active, not recruiting
    - Investigational Site Number : 2081001
France
- - Calais, France, 62107
    - Recruiting
    - Investigational Site Number : 2501017
  - Colmar, France, 68024
    - Recruiting
    - Investigational Site Number : 2501018
  - La Tronche, France, 38700
    - Recruiting
    - Investigational Site Number : 2501006
  - Lille, France, 59037
    - Recruiting
    - Investigational Site Number : 2501009
  - Nice, France, 06001
    - Recruiting
    - Investigational Site Number : 2501002
  - Saint-Herblain, France, 44800
    - Recruiting
    - Investigational Site Number : 2501010
Germany
- - Bielefeld, Germany, 33647
    - Recruiting
    - Investigational Site Number : 2761009
  - Bochum, Germany, 44791
    - Recruiting
    - Investigational Site Number : 2760010
  - Böblingen, Germany, 71034
    - Recruiting
    - Investigational Site Number : 2761016
  - Dresden, Germany, 01307
    - Recruiting
    - Investigational Site Number : 2760012
  - Düsseldorf, Germany, 40225
    - Recruiting
    - Investigational Site Number : 2760002
  - Erbach im Odenwald, Germany, 64711
    - Recruiting
    - Investigational Site Number : 2761013
  - Essen, Germany, 45147
    - Recruiting
    - Investigational Site Number : 2761011
  - Giessen, Germany, 35392
    - Recruiting
    - Investigational Site Number : 2761017
  - Heidelberg, Germany, 69117
    - Recruiting
    - Investigational Site Number : 2761014
  - Jena, Germany, 07747
    - Active, not recruiting
    - Investigational Site Number : 2761007
  - Leipzig, Germany, 04103
    - Recruiting
    - Investigational Site Number : 2760003
  - Marburg, Germany, 35043
    - Recruiting
    - Investigational Site Number : 2761008
  - Münster, Germany, 48149
    - Recruiting
    - Investigational Site Number : 2761006
  - Ulm, Germany, 89073
    - Recruiting
    - Investigational Site Number : 2760001
Greece
- - Athens, Greece, 124 62
    - Recruiting
    - Investigational Site Number : 3001005
  - Ioannina, Greece, 455 00
    - Recruiting
    - Investigational Site Number : 3000004
  - Larissa, Greece, 411 10
    - Recruiting
    - Investigational Site Number : 3001001
  - Thessaloniki, Greece, 546 36
    - Recruiting
    - Investigational Site Number : 3000002
  - Thessaloniki, Greece, 552 36
    - Recruiting
    - Investigational Site Number : 3001006
Hong Kong
- - Shatin, Hong Kong, 999077
    - Recruiting
    - Investigational Site Number : 3441001
Hungary
- - Budapest, Hungary, 1033
    - Recruiting
    - Investigational Site Number : 3481003
  - Budapest, Hungary, 1138
    - Recruiting
    - Investigational Site Number : 3481004
  - Győr, Hungary, 9024
    - Recruiting
    - Investigational Site Number : 3480002
  - Kaposvár, Hungary, 7400
    - Recruiting
    - Investigational Site Number : 3480001
  - Pécs, Hungary, 7623
    - Recruiting
    - Investigational Site Number : 3481005
India
- - Bengaluru, India, 560022
    - Recruiting
    - Investigational Site Number : 3561024
  - Chandigarh, India, 160012
    - Active, not recruiting
    - Investigational Site Number : 3560002
  - Hyderabad, India, 500082
    - Recruiting
    - Investigational Site Number : 3561008
  - Kochi, India, 682040
    - Recruiting
    - Investigational Site Number : 3560020
  - Nagpur, India, 440012
    - Active, not recruiting
    - Investigational Site Number : 3560010
  - Nashik, India, 422005
    - Active, not recruiting
    - Investigational Site Number : 3561005
  - New Delhi, India, 110029
    - Active, not recruiting
    - Investigational Site Number : 3560017
  - New Delhi, India, 110060
    - Active, not recruiting
    - Investigational Site Number : 3561023
  - Shimla, India, 171001
    - Active, not recruiting
    - Investigational Site Number : 3561006
  - Thiruvananthapuram, India, 695011
    - Active, not recruiting
    - Investigational Site Number : 3561004
Israel
- - Haifa, Israel, 3109601
    - Recruiting
    - Investigational Site Number : 3760001
  - Ramat Gan, Israel, 5262100
    - Recruiting
    - Investigational Site Number : 3760003
  - Safed, Israel, 1311001
    - Recruiting
    - Investigational Site Number : 3760002
Italy
- - Catania, Italy, 95123
    - Recruiting
    - Investigational Site Number : 3801012
  - Chieti, Italy, 66100
    - Recruiting
    - Investigational Site Number : 3800014
  - Como, Italy, 22100
    - Recruiting
    - Ospedale Valduce-Site Number : 3800033
    - Contact:
      
      Francesca Sangalli
      
      Phone Number: + 39 031 324630
      
      Email: fsangalli@valduce.it
    - Principal Investigator:
      
      Francesca Sangalli
  - Foggia, Italy, 71100
    - Recruiting
    - Policlinico "Riuniti" di Foggia-Site Number : 3800019
    - Contact:
      
      Annamaria Greco
      
      Phone Number: 0039 3299698701
      
      Email: annamaria.greco@unifg.it
    - Contact:
      
      EMANUELE D'AMICO
      
      Phone Number: 0039 3478640929
      
      Email: emanuele.damico@unifg.it
    - Principal Investigator:
      
      EMANUELE D'AMICO
  - Modena, Italy, 41125
    - Recruiting
    - A.O.U di Modena - Centro Sclerosi Multipla, Ospedale Civile di Baggiovara-Site Number : 3801028
    - Contact:
      
      Martina Cardi
      
      Phone Number: 39 0593961678
      
      Email: martinacardi20@gmail.com
    - Contact:
      
      Diana Ferraro
      
      Phone Number: 39 0593962251
      
      Email: Diana.ferraro@unimore.it
    - Principal Investigator:
      
      Diana Ferraro
  - Novara, Italy, 28100
    - Recruiting
    - AOU maggiore della carità di Novara-Site Number : 3801026
    - Contact:
      
      Domiziana Vecchio
      
      Email: domizia.vecchio@maggioreosp.novara.it
    - Contact:
      
      Sofia Asaro
      
      Email: sofia.asaro@maggioreosp.novara.it
    - Principal Investigator:
      
      Domiziana Vecchio
  - Palermo, Italy, 90127
    - Recruiting
    - Investigational Site Number : 3801022
  - Palermo, Italy, 90127
    - Recruiting
    - Policlinico "P.Giaccone"U.O.C. di Neurologia - Centro Sclerosi Multipla-Site Number : 3800017
    - Contact:
      
      Giuseppe Salemi
      
      Email: giuseppe.salemi@unipa.it
    - Contact:
      
      Francesca Madoni
      
      Email: francescamado@libero.it
    - Principal Investigator:
      
      Giuseppe Salemi
  - Parma, Italy, 43100
    - Recruiting
    - Investigational Site Number : 3801029
  - Pavia, Italy, 27100
    - Recruiting
    - Investigational Site Number : 3801005
  - Ravenna, Italy, 48121
    - Recruiting
    - Investigational Site Number : 3801030
  - Udine, Italy, 33100
    - Recruiting
    - Investigational Site Number : 3801031
  - Verona, Italy, 37134
    - Recruiting
    - Investigational Site Number : 3800020
- Ferrara
  - Cona, Ferrara, Italy, 44124
    - Recruiting
    - Centro Sclerosi Multipla UO Neurologia Universitaria, Dipartimento di Neuroscienze, AOU S.Anna-Site Number : 3801025
    - Contact:
      
      Eleonora Baldi
      
      Phone Number: 532236431
      
      Email: e.baldi@ospfe.it
    - Contact:
      
      Laura Rabboni
      
      Email: laura.rabboni@edu.unife.it
    - Principal Investigator:
      
      Eleonora Baldi
- Firenze
  - Florence, Firenze, Italy, 50134
    - Recruiting
    - AOU CAREGGI-Site Number : 3800004
    - Contact:
      
      SILVIA PERUGINI
      
      Email: centromd@aou-careggi.toscana.it
    - Principal Investigator:
      
      Maria Pia Amto
- Genova
  - Genoa, Genova, Italy, 16132
    - Recruiting
    - Investigational Site Number : 3801011
- Milano
  - Milan, Milano, Italy, 20132
    - Recruiting
    - Investigational Site Number : 3800002
  - Milan, Milano, Italy, 20133
    - Recruiting
    - Investigational Site Number : 3800016
- Monza E Brianza
  - Monza, Monza E Brianza, Italy, 20052
    - Recruiting
    - Investigational Site Number : 3800032
- Napoli
  - Naples, Napoli, Italy, 80131
    - Recruiting
    - A.O.U. Università degli studi della Campania Luigi Vanvitelli, II Clinica Neurologica-Site Number : 3801010
    - Contact:
      
      Filomena Napolitano
      
      Phone Number: 0039 081 566 6603
      
      Email: mena.nap1987@libero.it
    - Contact:
      
      Daisy De Luca
      
      Phone Number: 0039 081 566 6603
      
      Email: daisydeluca@libero.it
    - Principal Investigator:
      
      Elisabetta Signoriello
- Roma
  - Rome, Roma, Italy, 00133
    - Recruiting
    - Investigational Site Number : 3800015
  - Rome, Roma, Italy, 00149
    - Recruiting
    - Investigational Site Number : 3800001
  - Rome, Roma, Italy, 00161
    - Recruiting
    - Investigational Site Number : 3801013
  - Rome, Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800021
    - Contact:
      
      Massimiliano Mirabella
      
      Email: percorso.smultipla@policlinicogemelli.it
    - Principal Investigator:
      
      Massimiliano Mirabella
- Torino
  - Orbassano, Torino, Italy, 10043
    - Recruiting
    - AOU S. Luigi Gonzaga-Site Number : 3801024
    - Contact:
      
      Chiara Sciolla
      
      Email: info.cresm@sanluigi.piemonte.it
    - Principal Investigator:
      
      Alessia Di Sapio
Japan
- - Chiba, Japan, 260-8677
    - Recruiting
    - Investigational Site Number : 3920002
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Investigational Site Number : 3920013
  - Kyoto, Japan, 616-8255
    - Recruiting
    - Investigational Site Number : 3920001
  - Tokyo, Japan, 145-0065
    - Recruiting
    - Investigational Site Number : 3920011
  - Tokyo, Japan, 152-8902
    - Recruiting
    - Investigational Site Number : 3920004
  - Tokyo, Japan, 160-8582
    - Recruiting
    - Investigational Site Number : 3920012
- Fukushima
  - Kōriyama, Fukushima, Japan, 963-8052
    - Recruiting
    - Investigational Site Number : 3920003
- Hokkaido
  - Asahikawa, Hokkaido, Japan, 070-8530
    - Recruiting
    - Investigational Site Number : 3920006
  - Asahikawa, Hokkaido, Japan, 070-0901
    - Recruiting
    - Investigational Site Number : 3920014
  - Sapporo, Hokkaido, Japan, 063-0005
    - Recruiting
    - Investigational Site Number : 3920017
- Isernia
  - Joyo-Shi, Isernia, Japan, 610-0113
    - Recruiting
    - Investigational Site Number : 3800008
- Iwate
  - Yahaba, Iwate, Japan, 028-3695
    - Recruiting
    - Investigational Site Number : 3920008
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-0315
    - Recruiting
    - Investigational Site Number : 3920010
- Saitama
  - Higashi-Matsuyama, Saitama, Japan, 355-0005
    - Recruiting
    - Investigational Site Number : 3920015
- Tokyo
  - Kodaira, Tokyo, Japan, 187-8551
    - Recruiting
    - Investigational Site Number : 3920016
  - Tachikawa, Tokyo, Japan, 190-8531
    - Recruiting
    - Investigational Site Number : 3920009
Lithuania
- - Vilnius, Lithuania, 08661
    - Active, not recruiting
    - Investigational Site Number : 4401001
Malaysia
- - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Investigational Site Number : 4581001
Mexico
- - Tlalnepantla, Mexico, 54055
    - Recruiting
    - Investigational Site Number : 4841003
  - Veracruz, Mexico, 91900
    - Recruiting
    - Investigational Site Number : 4840001
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
    - Recruiting
    - Investigational Site Number : 4841007
- Mexico City
  - Mexico City, Mexico City, Mexico, 04700
    - Recruiting
    - Investigational Site Number : 4841009
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Recruiting
    - Investigational Site Number : 4840002
- Sinaloa
  - Culiacán, Sinaloa, Mexico, 80020
    - Recruiting
    - Investigational Site Number : 4841005
- Yucatán
  - Mérida, Yucatán, Mexico, 97070
    - Recruiting
    - Investigational Site Number : 4840011
Poland
- - Krakow, Poland, 31-271
    - Recruiting
    - Investigational Site Number : 6161014
- Greater Poland Voivodeship
  - Plewiska, Greater Poland Voivodeship, Poland, 62-064
    - Recruiting
    - Investigational Site Number : 6160002
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
    - Active, not recruiting
    - Investigational Site Number : 6160018
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-501
    - Active, not recruiting
    - Investigational Site Number : 6161005
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-002
    - Recruiting
    - Investigational Site Number : 6161017
- Lódzkie
  - Lodz, Lódzkie, Poland, 90-324
    - Active, not recruiting
    - Investigational Site Number : 6161008
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-172
    - Completed
    - Investigational Site Number : 6161016
- Podkarpackie Voivodeship
  - Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
    - Recruiting
    - Investigational Site Number : 6160006
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-686
    - Recruiting
    - Investigational Site Number : 6160019
  - Katowice, Silesian Voivodeship, Poland, 40571
    - Recruiting
    - Investigational Site Number : 6161011
  - Katowice, Silesian Voivodeship, Poland, 40-081
    - Active, not recruiting
    - Investigational Site Number : 6161010
  - Zabrze, Silesian Voivodeship, Poland, 41-800
    - Recruiting
    - Investigational Site Number : 6160004
  - Żory, Silesian Voivodeship, Poland, 44-240
    - Active, not recruiting
    - Investigational Site Number : 6160020
- Świętokrzyskie Voivodeship
  - Kielce, Świętokrzyskie Voivodeship, Poland, 25-726
    - Active, not recruiting
    - Investigational Site Number : 6161015
Portugal
- - Braga, Portugal, 4710-243
    - Recruiting
    - Investigational Site Number : 6200001
  - Coimbra, Portugal, 3000-075
    - Recruiting
    - Investigational Site Number : 6201005
  - Guimarães, Portugal, 4800-055
    - Recruiting
    - Investigational Site Number : 6200009
  - Lisbon, Portugal, 1169-050
    - Recruiting
    - Investigational Site Number : 6201011
  - Lisbon, Portugal, 1500-650
    - Recruiting
    - Investigational Site Number : 6201012
  - Matosinhos Municipality, Portugal, 4464-513
    - Recruiting
    - Investigational Site Number : 6200002
Puerto Rico
- - Guaynabo, Puerto Rico, 00969
    - Recruiting
    - San Juan MS Center- Site Number : 8401106
Romania
- - Bucharest, Romania, 050098
    - Recruiting
    - Investigational Site Number : 6421004
  - Campulung Muscel, Romania, 115100
    - Recruiting
    - Investigational Site Number : 6420002
  - Constanța, Romania, 900123
    - Recruiting
    - Investigational Site Number : 6421001
Saudi Arabia
- - Riyadh, Saudi Arabia, 11525
    - Recruiting
    - Investigational Site Number : 6820002
  - Riyadh, Saudi Arabia, 11461
    - Recruiting
    - Investigational Site Number : 6820001
Singapore
- - Singapore, Singapore, 308433
    - Recruiting
    - Investigational Site Number : 7021001
Slovakia
- - Bratislava, Slovakia, 833 05
    - Active, not recruiting
    - Investigational Site Number : 7031001
  - Martin, Slovakia, 036 01
    - Active, not recruiting
    - Investigational Site Number : 7030007
  - Nitra, Slovakia, 950 01
    - Recruiting
    - Investigational Site Number : 7030004
  - Trnava, Slovakia, 917 75
    - Active, not recruiting
    - Investigational Site Number : 7030003
South Africa
- - Cape Town, South Africa, 7405
    - Recruiting
    - Investigational Site Number : 7101002
  - Pretoria, South Africa, 0040
    - Recruiting
    - Investigational Site Number : 7101001
South Korea
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10408
    - Recruiting
    - Investigational Site Number : 4100001
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Investigational Site Number : 4100007
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, South Korea, 02841
    - Recruiting
    - Investigational Site Number : 4100006
  - Seoul, Seoul-teukbyeolsi, South Korea, 03080
    - Recruiting
    - Investigational Site Number : 4100002
  - Seoul, Seoul-teukbyeolsi, South Korea, 03722
    - Recruiting
    - Investigational Site Number : 4100004
  - Seoul, Seoul-teukbyeolsi, South Korea, 06351
    - Recruiting
    - Investigational Site Number : 4100003
  - Seoul, Seoul-teukbyeolsi, South Korea, 06591
    - Recruiting
    - Investigational Site Number : 4100008
Spain
- - Córdoba, Spain, 14004
    - Active, not recruiting
    - Investigational Site Number : 7240004
  - Madrid, Spain, 28006
    - Active, not recruiting
    - Investigational Site Number : 7240006
  - Madrid, Spain, 28034
    - Active, not recruiting
    - Investigational Site Number : 7240002
  - Madrid, Spain, 28040
    - Active, not recruiting
    - Investigational Site Number : 7240003
  - Madrid, Spain, 28007
    - Active, not recruiting
    - Investigational Site Number : 7241023
  - Madrid, Spain, 28040
    - Active, not recruiting
    - Investigational Site Number : 7241022
  - Málaga, Spain, 29010
    - Active, not recruiting
    - Investigational Site Number : 7240005
  - Valladolid, Spain, 47003
    - Active, not recruiting
    - Investigational Site Number : 7240011
- Almería
  - Murcia, Almería, Spain, 30120
    - Active, not recruiting
    - Investigational Site Number : 7240018
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spain, 08035
    - Active, not recruiting
    - Investigational Site Number : 7240010
- Basque Country
  - Barakaldo, Basque Country, Spain, 48903
    - Completed
    - Investigational Site Number : 7241009
- Las Palmas
  - Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
    - Active, not recruiting
    - Investigational Site Number : 7240013
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Active, not recruiting
    - Investigational Site Number : 7240001
- Pontevedra [Pontevedra]
  - Pontevedra, Pontevedra [Pontevedra], Spain, 36312
    - Active, not recruiting
    - Investigational Site Number : 7241014
- Sevilla
  - Seville, Sevilla, Spain, 41009
    - Active, not recruiting
    - Investigational Site Number : 7240007
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Investigational Site Number : 7561001
- Newfoundland and Labrador
  - Lausanne, Newfoundland and Labrador, Switzerland, 1004
    - Recruiting
    - Investigational Site Number : 1240007
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Recruiting
    - Investigational Site Number : 1581001
Thailand
- - Bangkok, Thailand, 10330
    - Recruiting
    - Investigational Site Number : 7641002
  - Bangkok, Thailand, 10700
    - Recruiting
    - Investigational Site Number : 7641001
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Investigational Site Number : 7641004
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06800
    - Recruiting
    - Investigational Site Number : 7920011
  - Ankara, Turkey (Türkiye), 06010
    - Active, not recruiting
    - Investigational Site Number : 7921018
  - Bursa, Turkey (Türkiye), 16310
    - Recruiting
    - Investigational Site Number : 7921013
  - Bursa, Turkey (Türkiye), 16059
    - Active, not recruiting
    - Investigational Site Number : 7921020
  - Eskişehir, Turkey (Türkiye), 26480
    - Recruiting
    - Investigational Site Number : 7921005
  - Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Investigational Site Number : 7920002
  - Istanbul, Turkey (Türkiye), 34010
    - Recruiting
    - Investigational Site Number : 7920012
  - Istanbul, Turkey (Türkiye), 34200
    - Recruiting
    - Investigational Site Number : 7921016
  - Istanbul, Turkey (Türkiye), 34668
    - Recruiting
    - Investigational Site Number : 7921009
  - Istanbul, Turkey (Türkiye), 34785
    - Recruiting
    - Investigational Site Number : 7920007
  - Izmir, Turkey (Türkiye), 35340
    - Recruiting
    - Investigational Site Number : 7921019
  - Izmir, Turkey (Türkiye), 35360
    - Active, not recruiting
    - Investigational Site Number : 7920008
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Investigational Site Number : 7921014
  - Konya, Turkey (Türkiye), 42075
    - Recruiting
    - Investigational Site Number : 7920015
  - Mersin, Turkey (Türkiye), 33070
    - Recruiting
    - Investigational Site Number : 7921006
  - Samsun, Turkey (Türkiye), 55139
    - Recruiting
    - Investigational Site Number : 7921004
  - Sultangazi, Turkey (Türkiye), 34265
    - Recruiting
    - Investigational Site Number : 7920003
  - Van, Turkey (Türkiye), 65080
    - Recruiting
    - Investigational Site Number : 7920017
  - İzmit, Turkey (Türkiye), 41001
    - Recruiting
    - Investigational Site Number : 7920001
Ukraine
- - Chernivtsi, Ukraine, 58023
    - Recruiting
    - Investigational Site Number : 8040001
  - Chernivtsi, Ukraine, 58000
    - Recruiting
    - Investigational Site Number : 8040007
  - Ivano-Frankivsk, Ukraine, 76019
    - Recruiting
    - Investigational Site Number : 8040009
  - Krykhivtsi, Ukraine, 76493
    - Recruiting
    - Investigational Site Number : 8041003
  - Kyiv, Ukraine, 02091
    - Recruiting
    - Investigational Site Number : 8041006
  - Lutsk, Ukraine, 43005
    - Recruiting
    - Investigational Site Number : 8040008
  - Lviv, Ukraine, 79010
    - Recruiting
    - Investigational Site Number : 8040004
  - Lviv, Ukraine, 79029
    - Recruiting
    - Investigational Site Number : 8041002
  - Vinnytsia, Ukraine, 21050
    - Recruiting
    - Investigational Site Number : 8041005
United Arab Emirates
- - Abu Dhabi, United Arab Emirates, 15258
    - Recruiting
    - Investigational Site Number : 7840002
  - Abu Dhabi, United Arab Emirates, 15258
    - Recruiting
    - Investigational Site Number : 7841002
United Kingdom
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Recruiting
    - Investigational Site Number : 8260001
- England
  - London, England, United Kingdom, E11 1NR
    - Recruiting
    - Investigational Site Number : 8260013
- Highland
  - Inverness, Highland, United Kingdom, IV2 3UJ
    - Recruiting
    - Investigational Site Number : 8260010
- Kent
  - Canterbury, Kent, United Kingdom, CT1 3NG
    - Recruiting
    - Investigational Site Number : 8261003
- Manchester
  - Salford, Manchester, United Kingdom, M6 8HD
    - Recruiting
    - Investigational Site Number : 8261008
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - University of Alabama at Birmingham- Site Number : 8401135
  - Cullman, Alabama, United States, 35058
    - Recruiting
    - North Central Neurology Associates- Site Number : 8401100
  - Homewood, Alabama, United States, 35209
    - Recruiting
    - Alabama Neurology Associates- Site Number : 8400115
- Arizona
  - Phoenix, Arizona, United States, 85013
    - Recruiting
    - St. Joseph's Hospital and Medical Center- Site Number : 8401139
  - Scottsdale, Arizona, United States, 85258
    - Recruiting
    - Clinical Endpoints- Site Number : 8400050
  - Scottsdale, Arizona, United States, 85253
    - Recruiting
    - Perseverance Research Center- Site Number : 8401138
- California
  - Carlsbad, California, United States, 92011
    - Recruiting
    - The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
  - Irvine, California, United States, 92697
    - Recruiting
    - University of California Irvine - School of Medicine- Site Number : 8401143
  - Laguna Hills, California, United States, 92653
    - Recruiting
    - Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
  - Lancaster, California, United States, 93534
    - Recruiting
    - Chemidox Clinical Trials- Site Number : 8401157
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Hoag Memorial Hospital Presbyterian- Site Number : 8401031
  - West Hollywood, California, United States, 90048
    - Recruiting
    - Private Practice - Dr. Regina Berkovich- Site Number : 8400005
- Colorado
  - Aurora, Colorado, United States, 80045
    - Completed
    - University of Colorado - Anschutz Medical Campus- Site Number : 8401001
  - Fort Collins, Colorado, United States, 80528
    - Active, not recruiting
    - Advanced Neurology of Colorado- Site Number : 8401148
- Connecticut
  - Norwich, Connecticut, United States, 06360
    - Recruiting
    - Hartford Healthcare Medical Group- Site Number : 8401069
  - Stamford, Connecticut, United States, 06905
    - Recruiting
    - New England Institute for Clinical Research- Site Number : 8400114
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - MedStar Georgetown University Hospital- Site Number : 8400044
- Florida
  - Altamonte Springs, Florida, United States, 32714
    - Recruiting
    - Neurology of Central Florida- Site Number : 8401147
  - Boca Raton, Florida, United States, 33428
    - Recruiting
    - Neurology Offices of South Florida - Boca Raton- Site Number : 8401169
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071
  - Bradenton, Florida, United States, 34209
    - Recruiting
    - Nova Clinical Research - Bradenton- Site Number : 8400189
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic in Florida- Site Number : 8401093
  - Maitland, Florida, United States, 32751
    - Recruiting
    - Neurology Associates - Maitland- Site Number : 8400010
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami Hospital- Site Number : 8401177
  - Miami Lakes, Florida, United States, 33016
    - Recruiting
    - Design Neuroscience Center- Site Number : 8401191
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
  - Tampa, Florida, United States, 33612
    - Recruiting
    - University of South Florida- Site Number : 8400013
  - Tampa, Florida, United States, 33609
    - Recruiting
    - Axiom Clinical Research of Florida- Site Number : 8400049
  - West Palm Beach, Florida, United States, 33407
    - Recruiting
    - Palm Beach Neurology- Site Number : 8401105
- Georgia
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
  - Smyrna, Georgia, United States, 30080
    - Recruiting
    - Joi Life Wellness Group LLC- Site Number : 8401192
- Illinois
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8401111
  - Northbrook, Illinois, United States, 60062
    - Recruiting
    - Consultants in Neurology- Site Number : 8401020
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Springfield Clinic 1st - 900 Building- Site Number : 8400043
- Indiana
  - Fort Wayne, Indiana, United States, 46815
    - Recruiting
    - IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058
  - Merrillville, Indiana, United States, 46410
    - Recruiting
    - Neuroscience Institute Center- Site Number : 8400053
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa- Site Number : 8400029
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - University of Kansas Medical Center- Site Number : 8400084
  - Roeland Park, Kansas, United States, 66205
    - Recruiting
    - KC Research Center- Site Number : 8400032
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Recruiting
    - Baptist Health Lexington- Site Number : 8401149
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Norton Neurology Services- Site Number : 8401103
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Recruiting
    - NeuroMedical Clinic of Central Louisiana- Site Number : 8401159
  - Baton Rouge, Louisiana, United States, 70810
    - Recruiting
    - The NeuroMedical Center- Site Number : 8401182
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
- Maryland
  - Lutherville, Maryland, United States, 21093
    - Recruiting
    - International Neurorehabilitation Institute- Site Number : 8400089
- Massachusetts
  - Boston, Massachusetts, United States, 02131
    - Recruiting
    - Boston Clinical Trials- Site Number : 8401178
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center - Boston- Site Number : 8401041
  - Foxborough, Massachusetts, United States, 02035
    - Recruiting
    - Neurology Center of New England- Site Number : 8401164
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Hospital- Site Number : 8401091
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Michigan Institute for Neurological Disorders- Site Number : 8400004
  - Owosso, Michigan, United States, 48867
    - Active, not recruiting
    - Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
  - Rochester Hills, Michigan, United States, 48307
    - Active, not recruiting
    - Rochester Medical Group- Site Number : 8401172
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - Recruiting
    - M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056
  - Plymouth, Minnesota, United States, 55446
    - Recruiting
    - Minnesota Center for Multiple Sclerosis- Site Number : 8400073
- Missouri
  - Ozark, Missouri, United States, 65721
    - Recruiting
    - Sharlin Health and Neurology- Site Number : 8400016
  - St Louis, Missouri, United States, 63131
    - Recruiting
    - The MS Center for Innovations in Care- Site Number : 8401141
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University- Site Number : 8400076
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Recruiting
    - Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
  - Reno, Nevada, United States, 89502
    - Recruiting
    - Renown Regional Medical Center- Site Number : 8400066
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Recruiting
    - Rutgers University- Site Number : 8401067
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Active, not recruiting
    - The University of New Mexico- Site Number : 8401090
- New York
  - Patchogue, New York, United States, 11772
    - Recruiting
    - South Shore Neurologic Associates - Patchogue- Site Number : 8400063
  - The Bronx, New York, United States, 10461
    - Recruiting
    - Montefiore Medical Center - Einstein Campus- Site Number : 8401145
- North Carolina
  - Charlotte, North Carolina, United States, 28210
    - Recruiting
    - Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - The Neurological Institute- Site Number : 8401166
  - Raleigh, North Carolina, United States, 27607
    - Recruiting
    - Raleigh Neurology Associates- Site Number : 8400014
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Active, not recruiting
    - Sanford Brain and Spine Center- Site Number : 8401085
- Ohio
  - Centerville, Ohio, United States, 45459
    - Recruiting
    - Dayton Center for Neurological Disorders- Site Number : 8400079
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - University of Cincinnati Medical Center- Site Number : 8401117
  - Columbus, Ohio, United States, 43235
    - Recruiting
    - The Boster Center for Multiple Sclerosis- Site Number : 8400006
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The Ohio State University- Site Number : 8401009
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - OhioHealth Riverside Methodist Hospital- Site Number : 8401092
  - Dayton, Ohio, United States, 45408
    - Recruiting
    - UC Health - Elizabeth Place- Site Number : 8401008
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - Oklahoma Medical Research Foundation- Site Number : 8400039
- Oregon
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence St. Vincent's Medical Center- Site Number : 8400052
  - Springfield, Oregon, United States, 97477
    - Recruiting
    - Oregon Neurology Associates- Site Number : 8400188
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Recruiting
    - Abington Neurological Associates- Site Number : 8401065
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Penn State Health Milton South Hershey Medical Center- Site Number : 8401176
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University Hospital- Site Number : 8400035
  - Pittsburgh, Pennsylvania, United States, 15212
    - Recruiting
    - Allegheny General Hospital- Site Number : 8401173
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - UPMC Magee-Womens Hospital- Site Number : 8401133
- South Carolina
  - Greer, South Carolina, United States, 29650
    - Recruiting
    - Premier Neurology- Site Number : 8401047
- Tennessee
  - Knoxville, Tennessee, United States, 37922
    - Recruiting
    - Hope Neurology- Site Number : 8400019
- Texas
  - Dallas, Texas, United States, 75243
    - Recruiting
    - Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
  - El Paso, Texas, United States, 79912
    - Recruiting
    - ANESC Research- Site Number : 8400187
  - Houston, Texas, United States, 77030
    - Recruiting
    - Baylor College of Medicine Medical Center- Site Number : 8401170
  - Plano, Texas, United States, 75024
    - Recruiting
    - North Texas Institute of Neurology & Headache - Plano- Site Number : 8401083
  - San Antonio, Texas, United States, 78258
    - Recruiting
    - Neurology Center of San Antonio- Site Number : 8400099
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - UT Health - San Antonio- Site Number : 8401167
  - Sherman, Texas, United States, 75092
    - Recruiting
    - Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109
  - Vienna, Virginia, United States, 22182
    - Recruiting
    - Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128
  - Virginia Beach, Virginia, United States, 23456
    - Recruiting
    - Sentara Family Medicine Physicians - Virginia Beach - Glenn Mitchell Drive- Site Number : 8401168
- Washington
  - Seattle, Washington, United States, 98104
    - Recruiting
    - Swedish Medical Center - Seattle- Site Number : 8400078
  - Seattle, Washington, United States, 98133
    - Recruiting
    - University of Washington Medical Center - Northwest- Site Number : 8401146
  - Tacoma, Washington, United States, 98405
    - Completed
    - MultiCare Tacoma General Hospital- Site Number : 8401140
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Recruiting
    - Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
The participant must have at least 1 of the following prior to screening:
- ≥1 documented relapse within the previous year OR
- ≥2 documented relapses within the previous 2 years, OR
- ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
The participant has a history of infection or may be at risk for infection:
The presence of psychiatric disturbance or substance abuse.
History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia.
A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
The participant has had a relapse in the 30 days prior to randomization.
The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frexalimab Participants will receive Frexalimab infusion and placebo tablet.	Drug: Frexalimab SAR441344 Solution for IV infusion Drug: MRI contrast-enhancing agents IV, as per respective label Drug: Placebo tablet Oral tablet Drug: Cholestyramine oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed. Drug: Activated charcoal oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.
Active Comparator: Teriflunomide Participants will receive teriflunomide tablet and placebo infusion.	Drug: MRI contrast-enhancing agents IV, as per respective label Drug: Cholestyramine oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed. Drug: Activated charcoal oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed. Drug: Teriflunomide Aubagio oral tablet Drug: Placebo infusion Solution for IV infusion

Participant Group / Arm

Intervention / Treatment

Experimental: Frexalimab

Participants will receive Frexalimab infusion and placebo tablet.

Drug: Frexalimab

SAR441344 Solution for IV infusion

Drug: MRI contrast-enhancing agents

IV, as per respective label

Drug: Placebo tablet

Oral tablet

Drug: Cholestyramine

oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.

Drug: Activated charcoal

oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Active Comparator: Teriflunomide

Participants will receive teriflunomide tablet and placebo infusion.

Drug: MRI contrast-enhancing agents

IV, as per respective label

Drug: Cholestyramine

oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.

Drug: Activated charcoal

oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Drug: Teriflunomide

Aubagio oral tablet

Drug: Placebo infusion

Solution for IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses Time Frame: Until Week 156	ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (<4, ≥4), and geographical region (US, non-US).	Until Week 156

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of cCDW, confirmed over 3 months Time Frame: Until Week 156		Until Week 156
Time to onset of individual components of the composite, confirmed over 3-months or 6-months Time Frame: Until Week 156		Until Week 156
Progression independent of relapse activity defined as the time to onset of 6-month cCDW Time Frame: Until Week 156	defined by either no prior relapse or an onset more than 90 days after the start date of the last investigatorreported relapse	Until Week 156
Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI Time Frame: Until Week 156	defined as the sum of the individual number of new Gd enhancing T1-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit divided by the number of scans	Until Week 156
Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6 Time Frame: From Week 24 to Week 156		From Week 24 to Week 156
Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT) Time Frame: From baseline to Week 156		From baseline to Week 156
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time Time Frame: From baseline to Week 156		From baseline to Week 156
Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time Time Frame: Until Week 156		Until Week 156
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period Time Frame: Until Week 168		Until Week 168
Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period Time Frame: Until Week 168	12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.	Until Week 168
Number of participants with antidrug (ADAs) over time Time Frame: Until Week 156		Until Week 156
Change from baseline in plasma neurofilament light chain (NfL) levels over time Time Frame: Until Week 144		Until Week 144
Frexalimab plasma concentration over time Time Frame: Until Week 144		Until Week 144
Time to onset of composite confirmed disability worsening (cCDW) Time Frame: Until Week 156	confirmed over 6 months as assessed by the composite of: increase from the baseline expanded disability status scale (EDSS) score of ≥1.5 points when the baseline is 0, or ≥1.0 point when the baseline is 0.5 to 5.0, or ≥0.5 point when the baseline is ≥5.5, OR increase of ≥20% from the baseline time in the 9-hole peg test (9HPT), OR increase of ≥20% from the baseline time in the Timed 25-foot walk (T25FW) test	Until Week 156
Time to onset of confirmed disability improvement (CDI) Time Frame: Until Week 156	defined as decrease from baseline EDSS score of ≥1.0 or ≥ 0.5 points when the baseline is ≥2 to ≤5.5 or >5.5 points, respectively, confirmed over 6 months. No improvement possible for 0 to 1.5 points	Until Week 156
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI Time Frame: Until Week 156	defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the EOS visit	Until Week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

May 6, 2027

Study Completion (Estimated)

May 6, 2027

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC17919
2023-504358-36 (Registry Identifier: CTIS)
U1111-1290-9326 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Multiple Sclerosis

Clinical Trials on Frexalimab

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