Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis (FREVIVA)

A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
• The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
• If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Frexalimab; Drug: MRI contrast-enhancing agents; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 943
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Investigational Site Number : 0320001
  • Buenos Aires, Argentina, 1012
    • Investigational Site Number : 0320002
  • Buenos Aires, Argentina, 1055
    • Investigational Site Number : 0321010
  • Buenos Aires, Argentina, 1060
    • Investigational Site Number : 0320007
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320003
• Australia
  • New South Wales
    • Saint Leonards, New South Wales, Australia, 2065
      • Investigational Site Number : 0360005
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Investigational Site Number : 0360001
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Investigational Site Number : 0360002
• Belgium
  • Bruges, Belgium, 8000
    • Investigational Site Number : 0560001
  • Brussels, Belgium, 1200
    • Investigational Site Number : 0560008
  • Ghent, Belgium, 9000
    • Investigational Site Number : 0560006
  • Kortrijk, Belgium, 8500
    • Investigational Site Number : 0560007
  • Melsbroek, Belgium, 1820
    • Investigational Site Number : 0560003
  • Overpelt, Belgium, 3900
    • Investigational Site Number : 0560005
• Brazil
  • São Paulo, Brazil, 01228-000
    • CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0760002
  • São Paulo, Brazil, 04038-002
    • PSEG Centro de Pesquisa Clínica- Site Number : 0760021
  • São Paulo, Brazil, 04515-000
    • Jordy Sinapse- Site Number : 0760004
  • São Paulo, Brazil, 05651-901
    • Hospital Israelita Albert Einstein- Site Number : 0760026
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055-450
      • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760029
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41820-020
      • Centro de Pesquisas da Clínica IBIS- Site Number : 0760030
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-020
      • Universidade Federal de Goias- Site Number : 0760024
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-320
      • Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
      • Hospital Moinhos de Vento- Site Number : 0760005
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-000
      • IMV Pesquisa Neurológica- Site Number : 0760031
    • Porto Alegre, Rio Grande do Sul, Brazil, 90480-020
      • Instituto Ceos- Site Number : 0760028
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89202-165
      • Clínica Neurológica- Site Number : 0760007
  • São Paulo
    • Santo André, São Paulo, Brazil, 09040-010
      • Prognosis Centro de Pesquisa- Site Number : 0760032
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Investigational Site Number : 1000009
  • Panagyurishte, Bulgaria, 4500
    • Investigational Site Number : 1000008
  • Pazardzhik, Bulgaria, 4400
    • Investigational Site Number : 1000007
  • Pleven, Bulgaria, 5800
    • Investigational Site Number : 1000010
  • Pleven, Bulgaria, 5800
    • Investigational Site Number : 1000002
  • Sofia, Bulgaria, 1431
    • Investigational Site Number : 1000001
  • Sofia, Bulgaria, 1407
    • Investigational Site Number : 1000004
  • Sofia, Bulgaria, 1606
    • Investigational Site Number : 1000006
  • Sofia, Bulgaria, 1680
    • Investigational Site Number : 1000005
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Investigational Site Number : 1240011
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 2X6
      • Investigational Site Number : 1240005
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Investigational Site Number : 1240010
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Investigational Site Number : 1240018
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Investigational Site Number : 1240014
    • Ottawa, Ontario, Canada, K1H 8L6
      • Investigational Site Number : 1240002
    • Toronto, Ontario, Canada, M4N 3M5
      • Investigational Site Number : 1240015
    • Toronto, Ontario, Canada, M5B 1W8
      • Investigational Site Number : 1240012
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 1W2
      • Investigational Site Number : 1240001
    • Lévis, Quebec, Canada, G6W 0M5
      • Investigational Site Number : 1240008
    • Montreal, Quebec, Canada, H2X 3E4
      • Investigational Site Number : 1240009
    • Québec, Quebec, Canada, G1J 1Z4
      • Investigational Site Number : 1240003
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Investigational Site Number : 1240006
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380456
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8320325
      • Investigational Site Number : 1520002
• China
  • Beijing, China, 100034
    • Investigational Site Number : 1560005
  • Beijing, China, 100005
    • Investigational Site Number : 1560007
  • Beijing, China, 100050
    • Investigational Site Number : 1560008
  • Changchun, China, 130021
    • Investigational Site Number : 1560003
  • Changsha, China, 410008
    • Investigational Site Number : 1560011
  • Chengdu, China, 610041
    • Investigational Site Number : 1560004
  • Fuzhou, China, 350005
    • Investigational Site Number : 1560045
  • Guangzhou, China, 510630
    • Investigational Site Number : 1560002
  • Harbin, China, 150001
    • Investigational Site Number : 1561027
  • Jiazhuang, China, 050000
    • Investigational Site Number : 1560010
  • Shanghai, China, 200040
    • Investigational Site Number : 1560001
  • Taiyuan, China, 030001
    • Investigational Site Number : 1560006
  • Tianjin, China, 300121
    • Investigational Site Number : 1560012
  • Wuhan, China, 430030
    • Investigational Site Number : 1560009
  • Xi'an, China, 710038
    • Investigational Site Number : 1560013
  • Zhengzhou, China, 450052
    • Investigational Site Number : 1560034
• Czechia
  • Brno, Czechia, 625 00
    • Investigational Site Number : 2030011
  • Brno, Czechia, 656 91
    • Investigational Site Number : 2030005
  • Hradec Králové, Czechia, 500 05
    • Investigational Site Number : 2030002
  • Jihlava, Czechia, 586 01
    • Investigational Site Number : 2030006
  • Ostrava, Czechia, 708 52
    • Investigational Site Number : 2030007
  • Prague, Czechia, 150 06
    • Investigational Site Number : 2030008
  • Teplice, Czechia, 415 01
    • Investigational Site Number : 2030009
  • Zlín, Czechia, 762 75
    • Investigational Site Number : 2030001
• France
  • Créteil, France, 94010
    • Investigational Site Number : 2500005
  • Gonesse, France, 95500
    • Investigational Site Number : 2500017
  • La Tronche, France, 38700
    • Investigational Site Number : 2500006
  • Lille, France, 59037
    • Investigational Site Number : 2500009
  • Nancy, France, 54035
    • Investigational Site Number : 2500016
  • Nice, France, 06001
    • Investigational Site Number : 2500002
  • Orsay, France, 91400
    • Investigational Site Number : 2500018
  • Paris, France, 75019
    • Investigational Site Number : 2500007
  • Paris, France, 75651
    • Investigational Site Number : 2500014
  • Rennes, France, 35033
    • Investigational Site Number : 2500003
  • Saint-Herblain, France, 44800
    • Investigational Site Number : 2500010
  • Strasbourg, France, 67200
    • Investigational Site Number : 2500001
• Germany
  • Bielefeld, Germany, 33647
    • Investigational Site Number : 2760009
  • Bochum, Germany, 44791
    • Investigational Site Number : 2760010
  • Dresden, Germany, 01307
    • Investigational Site Number : 2760012
  • Düsseldorf, Germany, 40225
    • Investigational Site Number : 2760002
  • Erbach im Odenwald, Germany, 64711
    • Investigational Site Number : 2760013
  • Essen, Germany, 45147
    • Investigational Site Number : 2760011
  • Heidelberg, Germany, 69117
    • Investigational Site Number : 2760014
  • Jena, Germany, 07747
    • Investigational Site Number : 2760007
  • Leipzig, Germany, 04103
    • Investigational Site Number : 2760003
  • Marburg, Germany, 35043
    • Investigational Site Number : 2760008
  • Münster, Germany, 48149
    • Investigational Site Number : 2760006
  • Ulm, Germany, 89073
    • Investigational Site Number : 2760001
• Greece
  • Athens, Greece, 124 62
    • Investigational Site Number : 3000005
  • Athens, Greece, 115 25
    • Investigational Site Number : 3000003
  • Ioannina, Greece, 455 00
    • Investigational Site Number : 3000004
  • Larissa, Greece, 411 10
    • Investigational Site Number : 3000001
  • Thessaloniki, Greece, 546 36
    • Investigational Site Number : 3000002
• Hungary
  • Budapest, Hungary, 1033
    • Investigational Site Number : 3480003
  • Budapest, Hungary, 1138
    • Investigational Site Number : 3480004
  • Budapest, Hungary, 1145
    • Investigational Site Number : 3480006
  • Győr, Hungary, 9024
    • Investigational Site Number : 3480002
• India
  • Bengaluru, India, 560022
    • Investigational Site Number : 3560024
  • Hyderabad, India, 500082
    • Investigational Site Number : 3560008
  • New Delhi, India, 110029
    • Investigational Site Number : 3560017
  • Shimla, India, 171001
    • Investigational Site Number : 3560006
• Italy
  • Bologna, Italy, 40139
    • Investigational Site Number : 3800009
  • Chieti, Italy, 66100
    • Investigational Site Number : 3800014
  • Foggia, Italy, 71100
    • Investigational Site Number : 3800019
  • Novara, Italy, 28100
    • Investigational Site Number : 3800026
  • Palermo, Italy, 90127
    • Investigational Site Number : 3800017
  • Parma, Italy, 43100
    • Investigational Site Number : 3800029
  • Pavia, Italy, 27100
    • Investigational Site Number : 3800005
  • Perugia, Italy, 06156
    • Investigational Site Number : 3800003
  • Ravenna, Italy, 48121
    • Investigational Site Number : 3800030
  • Catania
    • Augusta, Catania, Italy, 96011
      • Investigational Site Number : 3800034
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Investigational Site Number : 3800025
  • Firenze
    • Florence, Firenze, Italy, 50134
      • Investigational Site Number : 3800004
  • Genova
    • Genoa, Genova, Italy, 16132
      • Investigational Site Number : 3800011
  • Milano
    • Milan, Milano, Italy, 20132
      • Investigational Site Number : 3800002
    • Milan, Milano, Italy, 20133
      • Investigational Site Number : 3800016
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Investigational Site Number : 3800010
  • Palermo
    • Cefalù, Palermo, Italy, 90015
      • Investigational Site Number : 3800006
  • Roma
    • Rome, Roma, Italy, 00149
      • Investigational Site Number : 3800001
    • Rome, Roma, Italy, 00161
      • Investigational Site Number : 3800013
    • Rome, Roma, Italy, 00168
      • Investigational Site Number : 3800021
  • Varese
    • Gallarate, Varese, Italy, 21013
      • Investigational Site Number : 3800035
• Japan
  • Chiba, Japan, 260-8677
    • Investigational Site Number : 3920002
  • Fukuoka, Japan, 812-8582
    • Investigational Site Number : 3920013
  • Joyo-Shi, Japan, 610-0113
    • Investigational Site Number : 3800008
  • Kyoto, Japan, 616-8255
    • Investigational Site Number : 3920001
  • Tokyo, Japan, 145-0065
    • Investigational Site Number : 3920011
  • Tokyo, Japan, 160-8582
    • Investigational Site Number : 3920012
  • Toyama, Japan, 939-2716
    • Investigational Site Number : 2500015
  • Fukushima
    • Kōriyama, Fukushima, Japan, 963-8052
      • Investigational Site Number : 3920003
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0901
      • Investigational Site Number : 3920014
  • Hyōgo
    • Himeji, Hyōgo, Japan, 670-8560
      • Investigational Site Number : 3920007
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0315
      • Investigational Site Number : 3920010
  • Saitama
    • Higashi-Matsuyama, Saitama, Japan, 355-0005
      • Investigational Site Number : 3920015
  • Tokyo
    • Kodaira, Tokyo, Japan, 187-8551
      • Investigational Site Number : 3920016
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Investigational Site Number : 5280002
• Poland
  • Katowice, Poland, 40571
    • Investigational Site Number : 6160011
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-309
      • Investigational Site Number : 6160012
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Investigational Site Number : 6160018
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-501
      • Investigational Site Number : 6160005
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Investigational Site Number : 6160006
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-276
      • Investigational Site Number : 6160007
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-081
      • Investigational Site Number : 6160010
    • Zabrze, Silesian Voivodeship, Poland, 41-800
      • Investigational Site Number : 6160004
• Portugal
  • Braga, Portugal, 4710-243
    • Investigational Site Number : 6200001
  • Lisbon, Portugal, 1649-035
    • Investigational Site Number : 6200006
  • Lisbon, Portugal, 1349-019
    • Investigational Site Number : 6200007
  • Lisbon, Portugal, 1169-050
    • Investigational Site Number : 6200011
  • Matosinhos Municipality, Portugal, 4464-513
    • Investigational Site Number : 6200002
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11461
    • Investigational Site Number : 6820001
• South Korea
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10408
      • Investigational Site Number : 4100001
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Investigational Site Number : 4100007
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 03080
      • Investigational Site Number : 4100002
    • Seoul, Seoul-teukbyeolsi, South Korea, 03722
      • Investigational Site Number : 4100004
    • Seoul, Seoul-teukbyeolsi, South Korea, 06351
      • Investigational Site Number : 4100003
• Spain
  • Córdoba, Spain, 14004
    • Investigational Site Number : 7240004
  • Madrid, Spain, 28034
    • Investigational Site Number : 7240002
  • Madrid, Spain, 28006
    • Investigational Site Number : 7240006
  • Madrid, Spain, 28007
    • Investigational Site Number : 7240023
  • Madrid, Spain, 28040
    • Investigational Site Number : 7240003
  • Madrid, Spain, 28040
    • Investigational Site Number : 7240022
  • Málaga, Spain, 29010
    • Investigational Site Number : 7240005
  • Valencia, Spain, 46026
    • Investigational Site Number : 7240008
  • Zaragoza, Spain, 50009
    • Investigational Site Number : 7240025
  • Almería
    • Murcia, Almería, Spain, 30120
      • Investigational Site Number : 7240018
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240010
    • Barcelona, Barcelona [Barcelona], Spain, 08003
      • Investigational Site Number : 7240016
  • Basque Country
    • Barakaldo, Basque Country, Spain, 48903
      • Investigational Site Number : 7240009
  • Catalunya [Cataluña]
    • L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08907
      • Investigational Site Number : 7240011
  • Gipuzkoa
    • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
      • Investigational Site Number : 7240012
  • Girona [Gerona]
    • Girona, Girona [Gerona], Spain, 17190
      • Investigational Site Number : 7240024
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Investigational Site Number : 7240013
  • Lleida [Lérida]
    • Lleida, Lleida [Lérida], Spain, 25198
      • Investigational Site Number : 7240015
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Investigational Site Number : 7240017
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Investigational Site Number : 7240001
  • Pontevedra [Pontevedra]
    • Pontevedra, Pontevedra [Pontevedra], Spain, 36312
      • Investigational Site Number : 7240014
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Investigational Site Number : 7240007
• Sweden
  • Gothenburg, Sweden, 413 45
    • Investigational Site Number : 7520001
  • Huddinge, Sweden, 141 57
    • Investigational Site Number : 7520005
  • Malmö, Sweden, 205 02
    • Investigational Site Number : 7520003
  • Stockholm, Sweden, 113 65
    • Investigational Site Number : 7520002
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • Investigational Site Number : 7920018
  • Ankara, Turkey (Türkiye), 06800
    • Investigational Site Number : 7920011
  • Bursa, Turkey (Türkiye), 16059
    • Investigational Site Number : 7920020
  • Bursa, Turkey (Türkiye), 16310
    • Investigational Site Number : 7920013
  • Eskişehir, Turkey (Türkiye), 26480
    • Investigational Site Number : 7920005
  • Istanbul, Turkey (Türkiye), 34098
    • Investigational Site Number : 7920002
  • Istanbul, Turkey (Türkiye), 34785
    • Investigational Site Number : 7920007
  • Istanbul, Turkey (Türkiye), 34668
    • Investigational Site Number : 7920009
  • Istanbul, Turkey (Türkiye), 34010
    • Investigational Site Number : 7920012
  • Istanbul, Turkey (Türkiye), 34200
    • Investigational Site Number : 7920016
  • Izmir, Turkey (Türkiye), 35340
    • Investigational Site Number : 7920019
  • Izmir, Turkey (Türkiye), 35360
    • Investigational Site Number : 7920008
  • Kayseri, Turkey (Türkiye), 38039
    • Investigational Site Number : 7920014
  • Konya, Turkey (Türkiye), 42075
    • Investigational Site Number : 7920015
  • Mersin, Turkey (Türkiye), 33070
    • Investigational Site Number : 7920006
  • Samsun, Turkey (Türkiye), 55139
    • Investigational Site Number : 7920004
  • Sultangazi, Turkey (Türkiye), 34265
    • Investigational Site Number : 7920003
  • Van, Turkey (Türkiye), 65080
    • Investigational Site Number : 7920017
  • İzmit, Turkey (Türkiye), 41001
    • Investigational Site Number : 7920001
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • Investigational Site Number : 8040001
  • Ivano-Frankivsk, Ukraine, 76019
    • Investigational Site Number : 8040009
  • Krykhivtsi, Ukraine, 76493
    • Investigational Site Number : 8040003
  • Kyiv, Ukraine, 02091
    • Investigational Site Number : 8040006
  • Lutsk, Ukraine, 43005
    • Investigational Site Number : 8040008
  • Lviv, Ukraine, 79010
    • Investigational Site Number : 8040004
  • Lviv, Ukraine, 79029
    • Investigational Site Number : 8040002
  • Vinnytsia, Ukraine, 21050
    • Investigational Site Number : 8040005
• United Kingdom
  • Liverpool, United Kingdom, L97LJ
    • Investigational Site Number : 8260009
  • Blaenau Gwent
    • Gwent, Blaenau Gwent, United Kingdom, NP20 2UB
      • Investigational Site Number : 8260011
  • Cardiff [Caerdydd Gb-crd]
    • Cardiff, Cardiff [Caerdydd Gb-crd], United Kingdom, CF14 4XW
      • Investigational Site Number : 8260007
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Investigational Site Number : 8260001
  • England
    • London, England, United Kingdom, E11 1NR
      • Investigational Site Number : 8260013
    • Newcastle upon Tyne, England, United Kingdom, NE2 4HH
      • Investigational Site Number : 8260006
  • Highland
    • Inverness, Highland, United Kingdom, IV2 3UJ
      • Investigational Site Number : 8260010
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • Investigational Site Number : 8260003
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Investigational Site Number : 8260008
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Investigational Site Number : 8260004
  • Swansea [Abertawe Gb-ata]
    • Swansea, Swansea [Abertawe Gb-ata], United Kingdom, SA6 6SG
      • Investigational Site Number : 8260005
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Alabama Neurology Associates- Site Number : 8400115
  • Arizona
    • Scottsdale, Arizona, United States, 85253
      • Perseverance Research Center- Site Number : 8400138
    • Scottsdale, Arizona, United States, 85258
      • Imaging Endpoints- Site Number : 8400050
  • California
    • Berkeley, California, United States, 94705
      • Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134
    • Irvine, California, United States, 92697
      • University of California Irvine - School of Medicine- Site Number : 8400143
    • La Jolla, California, United States, 92037
      • University of California San Diego - La Jolla- Site Number : 8400095
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian- Site Number : 8400031
    • Palo Alto, California, United States, 94304
      • Stanford Neuroscience Health Center- Site Number : 8400120
    • West Hollywood, California, United States, 90048
      • Private Practice - Dr. Regina Berkovich- Site Number : 8400005
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado - Anschutz Medical Campus- Site Number : 8400001
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurology of Colorado- Site Number : 8400148
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine- Site Number : 8400081
    • Norwich, Connecticut, United States, 06360
      • Hartford Healthcare Medical Group- Site Number : 8400069
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital- Site Number : 8400044
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Neurology of Central Florida- Site Number : 8400147
    • Clearwater, Florida, United States, 33761
      • MS & Neuromuscular Center of Excellence- Site Number : 8400015
    • Gainesville, Florida, United States, 32608
      • Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054
    • Maitland, Florida, United States, 32751
      • Neurology Associates - Maitland- Site Number : 8400010
    • Orlando, Florida, United States, 32806
      • Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida- Site Number : 8400049
    • Tampa, Florida, United States, 33612
      • University of South Florida- Site Number : 8400013
    • West Palm Beach, Florida, United States, 33407
      • Palm Beach Neurology- Site Number : 8400105
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • Joi Life Wellness Group LLC- Site Number : 8400192
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center- Site Number : 8400102
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center- Site Number : 8400055
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology- Site Number : 8400020
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Neuroscience Institute Center- Site Number : 8400053
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • University of Iowa- Site Number : 8400029
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center- Site Number : 8400084
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington- Site Number : 8400149
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • NeuroMedical Clinic of Central Louisiana- Site Number : 8400159
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine - Baltimore- Site Number : 8400185
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital- Site Number : 8400080
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center- Site Number : 8400003
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials- Site Number : 8400178
    • Foxborough, Massachusetts, United States, 02035
      • Neurology Center of New England- Site Number : 8400164
    • Wellesley, Massachusetts, United States, 02481
      • The Elliot Lewis Center- Site Number : 8400033
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center - University Campus- Site Number : 8400028
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital- Site Number : 8400091
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Institute for Neurological Disorders- Site Number : 8400004
    • Grand Rapids, Michigan, United States, 49503
      • Trinity Health Grand Rapids- Site Number : 8400150
    • Owosso, Michigan, United States, 48867
      • Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Medical Group- Site Number : 8400172
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056
    • Plymouth, Minnesota, United States, 55446
      • Minnesota Center for Multiple Sclerosis- Site Number : 8400073
  • Missouri
    • Ozark, Missouri, United States, 65721
      • Sharlin Health and Neurology- Site Number : 8400016
    • St Louis, Missouri, United States, 63110
      • Washington University- Site Number : 8400076
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center- Site Number : 8400066
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center- Site Number : 8400101
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • The University of New Mexico- Site Number : 8400090
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute - Amherst- Site Number : 8400129
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai- Site Number : 8400011
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center- Site Number : 8400088
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates- Site Number : 8400014
    • Winston-Salem, North Carolina, United States, 27103
      • Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Sanford Brain and Spine Center- Site Number : 8400085
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Riverhills Neuroscience- Site Number : 8400007
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center- Site Number : 8400117
    • Columbus, Ohio, United States, 43210
      • The Ohio State University- Site Number : 8400009
    • Columbus, Ohio, United States, 43235
      • The Boster Center for Multiple Sclerosis- Site Number : 8400006
    • Dayton, Ohio, United States, 45408
      • UC Health - Elizabeth Place- Site Number : 8400008
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation- Site Number : 8400039
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent's Medical Center- Site Number : 8400052
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton South Hershey Medical Center- Site Number : 8400176
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Premier Neurology- Site Number : 8400047
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Vanderbilt Multiple Sclerosis Center- Site Number : 8400130
  • Texas
    • Dallas, Texas, United States, 75243
      • Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
    • Plano, Texas, United States, 75024
      • North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio- Site Number : 8400099
    • Sherman, Texas, United States, 75092
      • Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center- Site Number : 8400042
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center - Seattle- Site Number : 8400078
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
• Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
• Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
• Absence of clinical relapses for at least 24 months.
• The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Exclusion 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 immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
• 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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
• The participant was previously exposed to frexalimab.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: MRI contrast-enhancing agents; IV, as per respective label; Drug: Placebo; Solution for IV infusion
Experimental: Frexalimab; Frexalimab IV administration	Drug: Frexalimab; SAR441344 Solution for IV infusion; Drug: MRI contrast-enhancing agents; IV, as per respective label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period	Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is <5.5, 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	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period		Up to 36 months
Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period	increase from the baseline EDSS score of ≥1.0 point when the baseline is <5.5, or ≥0.5 point when the baseline is ≥5.5	Up to 36 months
Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period	defined as decrease from the baseline EDSS score of ≥1.0 or ≥ 0.5 points when baseline is ≤5.5 or >5.5 points, respectively, confirmed over 6 months.	Up to 36 months
Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI	defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to the end of double-blind treatment period	Up to 36 months
Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6		Up to 36 months
Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT)		Baseline, Up to 36 months
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period		Baseline, Up to 36 months
Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period		Baseline, Up to 36 months
Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses		Up to 36 months
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)		Up to 36 months
Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period	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.	Up to 36 months
Number of participants with antibody over time		Up to 36 months
Change from baseline in serum Ig levels over time		Up to 36 months
Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period		Up to 36 months
Frexalimab plasma concentration over time in the double-blind treatment period		Up to 36 months

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• EFC17504 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): March 24, 2028

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): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: EFC17504; U1111-1280-7114 (Registry Identifier: ICTRP); 2023-504359-29 (Registry Identifier: CTIS)

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: No