Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04458051
Other study ID # EFC16035
Secondary ID U1111-1238-13182
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 13, 2020
Est. completion date July 25, 2025

Study information

Verified date April 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168


Description:

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date July 25, 2025
Est. primary completion date July 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 18 to 55 years of age inclusive - Diagnosis of PPMS according to the 2017 McDonald criteria - Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive - Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history. - Contraceptive use consistent with local regulations for individuals participating in clinical studies - Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method - the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication). - the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: - Participant has conditions that would adversely affect study participation such as short life expectancy. - Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation. - Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator - History of malignancy within 5 years prior to screening. - History of alcohol or drug abuse within 1 year prior to Screening. - Hospitalized for psychiatric disease within 2 years prior to Screening. - Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening. - A bleeding disorder or known platelet dysfunction at any time prior to the screening visit. - A platelet count <150 000/µL at the screening visit. - A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal - Lymphocyte count below the lower limit of normal at Screening. - Recent live (attenuated) vaccine within 2 months before the first treatment visit. - Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study. - The participant has received medications/treatments for MS within a specified time frame. - Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes. - Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin). - Contraindications to magnetic resonance imaging (MRI). NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tolebrutinib
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Film-coated Tablet Route of administration: Oral

Locations

Country Name City State
Argentina Investigational Site Number : 0320002 Caba Buenos Aires
Argentina Investigational Site Number : 0320004 Caba Buenos Aires
Argentina Investigational Site Number : 0320003 Rosario Santa Fe
Australia Investigational Site Number : 0360005 Concord New South Wales
Australia Investigational Site Number : 0360003 Hobart Tasmania
Australia Investigational Site Number : 0360006 St Leonards New South Wales
Austria Investigational Site Number : 0400004 Linz
Austria Investigational Site Number : 0400002 Wien
Belarus Investigational Site Number : 1120004 Vitebsk
Belarus Investigational Site Number : 1120005 Vitebsk
Belgium Investigational Site Number : 0560009 Bruxelles
Belgium Investigational Site Number : 0560003 Edegem
Belgium Investigational Site Number : 0560004 Gent
Belgium Investigational Site Number : 0560006 Leuven
Belgium Investigational Site Number : 0560008 Liège
Belgium Investigational Site Number : 0560002 Mons
Belgium Investigational Site Number : 0560001 Pelt
Belgium Investigational Site Number : 0560007 Sint-Lambrechts-Woluwe
Bulgaria Investigational Site Number : 1000002 Pleven
Bulgaria Investigational Site Number : 1000001 Sofia
Bulgaria Investigational Site Number : 1000004 Sofia
Bulgaria Investigational Site Number : 1000008 Sofia
Bulgaria Investigational Site Number : 1000011 Sofia
Canada Investigational Site Number : 1240002 Edmonton Alberta
Canada Investigational Site Number : 1240012 Hamilton Ontario
Canada Investigational Site Number : 1240004 Montreal Quebec
Canada Investigational Site Number : 1240015 Montreal Quebec
Canada Investigational Site Number : 1240003 Ottawa Ontario
Canada Investigational Site Number : 1240001 Quebec
Canada Investigational Site Number : 1240021 Quebec
Canada Investigational Site Number : 1240007 Sherbrooke Quebec
Canada Investigational Site Number : 1240013 Toronto Ontario
Chile Investigational Site Number : 1520006 Concepcion Biobío
Chile Investigational Site Number : 1520001 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520002 Santiago Reg Metropolitana De Santiago
China Investigational Site Number : 1560003 Beijing
China Investigational Site Number : 1560009 Beijing
China Investigational Site Number : 1560012 Beijing
China Investigational Site Number : 1560021 Beijing
China Investigational Site Number : 1560025 Beijing
China Investigational Site Number : 1560004 Changchun
China Investigational Site Number : 1560015 Changsha
China Investigational Site Number : 1560005 Chengdu
China Investigational Site Number : 1560035 Fuzhou
China Investigational Site Number : 1560002 Guangzhou
China Investigational Site Number : 1560027 Hohhot
China Investigational Site Number : 1560001 Shanghai
China Investigational Site Number : 1560008 Taiyuan
China Investigational Site Number : 1560020 Tianjin
China Investigational Site Number : 1560026 Wenzhou
Colombia Investigational Site Number : 1700001 Bogota
Colombia Investigational Site Number : 1700003 Bogotá
Croatia Investigational Site Number : 1910001 Zagreb
Croatia Investigational Site Number : 1910002 Zagreb
Czechia Investigational Site Number : 2030002 Brno
Czechia Investigational Site Number : 2030004 Hradec Kralove
Czechia Investigational Site Number : 2030001 Jihlava
Czechia Investigational Site Number : 2030003 Teplice
Denmark Investigational Site Number : 2080001 Esbjerg
Denmark Investigational Site Number : 2080005 Holstebro
Estonia Investigational Site Number : 2330001 Tallinn
France Investigational Site Number : 2500011 Bron
France Investigational Site Number : 2500005 Clermont Ferrand
France Investigational Site Number : 2500015 Gonesse
France Investigational Site Number : 2500009 Lille
France Investigational Site Number : 2500006 Montpellier
France Investigational Site Number : 2500008 Nancy
France Investigational Site Number : 2500017 Nimes
France Investigational Site Number : 2500007 Paris
France Investigational Site Number : 2500014 Paris
France Investigational Site Number : 2500004 Poissy
France Investigational Site Number : 2500003 Rennes
France Investigational Site Number : 2500001 Strasbourg
France Investigational Site Number : 2500012 Toulouse
Georgia Investigational Site Number : 2680003 Tbilisi
Georgia Investigational Site Number : 2680004 Tbilisi
Georgia Investigational Site Number : 2680005 Tbilisi
Georgia Investigational Site Number : 2680006 Tbilisi
Georgia Investigational Site Number : 2680009 Tbilisi
Germany Investigational Site Number : 2760005 Bayreuth
Germany Investigational Site Number : 2760009 Berlin
Germany Investigational Site Number : 2760015 Berlin
Germany Investigational Site Number : 2760020 Bochum
Germany Investigational Site Number : 2760001 Dresden
Germany Investigational Site Number : 2760021 Düsseldorf
Germany Investigational Site Number : 2760012 Essen
Germany Investigational Site Number : 2760002 Gießen
Germany Investigational Site Number : 2760006 Hannover
Germany Investigational Site Number : 2760018 München
Germany Investigational Site Number : 2760008 Münster
Germany Investigational Site Number : 2760004 Rostock
Germany Investigational Site Number : 2760011 Ulm
Greece Investigational Site Number : 3000001 Athens
Greece Investigational Site Number : 3000002 Athens
Greece Investigational Site Number : 3000006 Athens
Greece Investigational Site Number : 3000004 Larissa
Greece Investigational Site Number : 3000007 Maroussi
Greece Investigational Site Number : 3000003 Thessaloniki
Greece Investigational Site Number : 3000009 Thessaloniki
Hungary Investigational Site Number : 3480202 Budapest
Hungary Investigational Site Number : 3480203 Budapest
Hungary Investigational Site Number : 3480205 Budapest
Hungary Investigational Site Number : 3480204 Kistarcsa
India Investigational Site Number : 3560014 Bengaluru
India Investigational Site Number : 3560003 Gurgaon
India Investigational Site Number : 3560007 Gurgaon
India Investigational Site Number : 3560004 Mangaluru
India Investigational Site Number : 3560002 New Delhi
India Investigational Site Number : 3560005 New Delhi
Israel Investigational Site Number : 3760008 Jerusalem
Israel Investigational Site Number : 3760001 Ramat Gan
Israel Investigational Site Number : 3760004 Safed
Italy Investigational Site Number : 3800007 Cagliari
Italy Investigational Site Number : 3800015 Catania
Italy Investigational Site Number : 3800018 Chieti
Italy Investigational Site Number : 3800016 Firenze
Italy Investigational Site Number : 3800001 Milano
Italy Investigational Site Number : 3800003 Napoli
Italy Investigational Site Number : 3800006 Napoli
Italy Investigational Site Number : 3800002 Pozzilli Isernia
Italy Investigational Site Number : 3800013 Roma
Japan Investigational Site Number : 3920014 Bunkyo-ku Tokyo
Japan Investigational Site Number : 3920016 Chiba-shi Chiba
Japan Investigational Site Number : 3920018 Kawagoe-shi Saitama
Japan Investigational Site Number : 3920003 Kodaira-shi Tokyo
Japan Investigational Site Number : 3920008 Koriyama-shi Fukushima
Japan Investigational Site Number : 3920011 Kyoto-shi Kyoto
Japan Investigational Site Number : 3920004 Moriguchi-shi Osaka
Japan Investigational Site Number : 3920022 Morioka-shi Iwate
Japan Investigational Site Number : 3920005 Niigata-shi Niigata
Japan Investigational Site Number : 3920001 Osaka-shi Osaka
Japan Investigational Site Number : 3920010 Ota-ku Tokyo
Japan Investigational Site Number : 3920023 Sagamihara-shi Kanagawa
Japan Investigational Site Number : 3920020 Sendai-shi Miyagi
Japan Investigational Site Number : 3920017 Shinjuku-ku Tokyo
Japan Investigational Site Number : 3920015 Toyama-shi Toyama
Latvia Investigational Site Number : 4280002 Riga
Latvia Investigational Site Number : 4280003 Riga
Mexico Investigational Site Number : 4840004 Guadalajara Jalisco
Mexico Investigational Site Number : 4840001 Mexico city
Mexico Investigational Site Number : 4840005 Mexico city
Mexico Investigational Site Number : 4840007 Tlalnepantla
Mexico Investigational Site Number : 4840003 Veracruz
Netherlands Investigational Site Number : 5280003 Breda
Netherlands Investigational Site Number : 5280006 Groningen
Netherlands Investigational Site Number : 5280002 Sittard-Geleen
Norway Investigational Site Number : 5780003 Bergen
Norway Investigational Site Number : 5780005 Tromsø
Peru Investigational Site Number : 6040004 Lima
Poland Investigational Site Number : 6160003 Bydgoszcz Kujawsko-pomorskie
Poland Investigational Site Number : 6160002 Katowice Slaskie
Poland Investigational Site Number : 6160004 Katowice Slaskie
Poland Investigational Site Number : 6160007 Katowice Slaskie
Poland Investigational Site Number : 6160001 Lodz Lódzkie
Poland Investigational Site Number : 6160005 Warszawa Mazowieckie
Poland Investigational Site Number : 6160006 Warszawa Mazowieckie
Portugal Investigational Site Number : 6200001 Braga
Portugal Investigational Site Number : 6200016 Leiria
Portugal Investigational Site Number : 6200007 Lisboa
Portugal Investigational Site Number : 6200012 Lisboa
Portugal Investigational Site Number : 6200002 Matosinhos
Portugal Investigational Site Number : 6200010 Porto
Portugal Investigational Site Number : 6200004 Santa Maria da Feira
Romania Investigational Site Number : 6420008 Bucuresti
Romania Investigational Site Number : 6420004 Campulung
Romania Investigational Site Number : 6420003 Constanta
Romania Investigational Site Number : 6420013 Oradea
Romania Investigational Site Number : 6420001 Targu Mures
Romania Investigational Site Number : 6420002 Timisoara
Russian Federation Investigational Site Number : 6430018 Barnaul
Russian Federation Investigational Site Number : 6430022 Ekaterinburg
Russian Federation Investigational Site Number : 6430023 Kaliningrad
Russian Federation Investigational Site Number : 6430004 Kazan
Russian Federation Investigational Site Number : 6430021 Krasnoyarsk
Russian Federation Investigational Site Number : 6430011 Moscow
Russian Federation Investigational Site Number : 6430013 Moscow
Russian Federation Investigational Site Number : 6430014 Nizhny Novgorod
Russian Federation Investigational Site Number : 6430008 Pyatigorsk
Russian Federation Investigational Site Number : 6430015 Rostov-on-Don
Russian Federation Investigational Site Number : 6430017 Saint-Petersburg
Russian Federation Investigational Site Number : 6430009 Samara
Russian Federation Investigational Site Number : 6430020 Saransk
Russian Federation Investigational Site Number : 6430007 Tyumen
Russian Federation Investigational Site Number : 6430006 Ufa
Serbia Investigational Site Number : 6880001 Belgrade
Serbia Investigational Site Number : 6880002 Kragujevac
Serbia Investigational Site Number : 6880004 Nis
Singapore Investigational Site Number : 7020002 Singapore
South Africa Investigational Site Number : 7100001 Pretoria
Spain Investigational Site Number : 7240010 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number : 7240013 Bilbao Bizkaia
Spain Investigational Site Number : 7240004 Córdoba
Spain Investigational Site Number : 7240012 La Coruña A Coruña [La Coruña]
Spain Investigational Site Number : 7240016 Las Palmas de Gran Canaria Las Palmas
Spain Investigational Site Number : 7240003 Madrid
Spain Investigational Site Number : 7240002 Majadahonda Madrid
Spain Investigational Site Number : 7240005 Malaga
Spain Investigational Site Number : 7240006 Murcia
Spain Investigational Site Number : 7240014 Palma de Mallorca
Spain Investigational Site Number : 7240001 Pozuelo De Alarcón Madrid
Spain Investigational Site Number : 7240011 Salt Girona [Gerona]
Spain Investigational Site Number : 7240015 Santiago de Compostela A Coruña [La Coruña]
Spain Investigational Site Number : 7240007 Sevilla Andalucia
Spain Investigational Site Number : 7240008 Valencia
Sweden Investigational Site Number : 7520001 Göteborg
Sweden Investigational Site Number : 7520005 Motala
Turkey Investigational Site Number : 7920009 Ankara
Turkey Investigational Site Number : 7920014 Ankara
Turkey Investigational Site Number : 7920005 Eskisehir
Turkey Investigational Site Number : 7920010 Hatay
Turkey Investigational Site Number : 7920002 Istanbul
Turkey Investigational Site Number : 7920003 Istanbul
Turkey Investigational Site Number : 7920007 Istanbul
Turkey Investigational Site Number : 7920016 Istanbul
Turkey Investigational Site Number : 7920015 Izmir
Turkey Investigational Site Number : 7920001 Izmit
Turkey Investigational Site Number : 7920011 Kutahya
Turkey Investigational Site Number : 7920012 Mersin
Turkey Investigational Site Number : 7920013 Samsun
Ukraine Investigational Site Number : 8040020 Chernivtsi
Ukraine Investigational Site Number : 8040012 Ivano-Frankivsk
Ukraine Investigational Site Number : 8040017 Kharkiv
Ukraine Investigational Site Number : 8040023 Kharkiv
Ukraine Investigational Site Number : 8040025 Kharkiv
Ukraine Investigational Site Number : 8040013 Kyiv
Ukraine Investigational Site Number : 8040014 Kyiv
Ukraine Investigational Site Number : 8040015 Kyiv
Ukraine Investigational Site Number : 8040011 Lutsk
Ukraine Investigational Site Number : 8040002 Lviv
Ukraine Investigational Site Number : 8040007 Lviv
Ukraine Investigational Site Number : 8040010 Odesa
Ukraine Investigational Site Number : 8040024 Vinnytsya
Ukraine Investigational Site Number : 8040008 Zhytormyr
United Kingdom Investigational Site Number : 8260009 Bristol
United Kingdom Investigational Site Number : 8260016 Canterbury Kent
United Kingdom Investigational Site Number : 8260001 Cardiff Vale Of Glamorgan, The
United Kingdom Investigational Site Number : 8260005 London London, City Of
United Kingdom Investigational Site Number : 8260006 London London, City Of
United Kingdom Investigational Site Number : 8260012 Nottingham Nottinghamshire
United Kingdom Investigational Site Number : 8260013 Oxford Oxfordshire
United Kingdom Investigational Site Number : 8260019 Salford
United Kingdom Investigational Site Number : 8260010 Swansea Neath Port Talbot
United States University of New Mexico Site Number : 8400032 Albuquerque New Mexico
United States South Florida Neurology Associates Site Number : 8400029 Boca Raton Florida
United States Tufts Medical Center Site Number : 8400072 Boston Massachusetts
United States Novant Health Multiple Sclerosis Care Center - South Park Site Number : 8400120 Charlotte North Carolina
United States Cleveland Clinic Site Number : 8400125 Cleveland Ohio
United States The Boster Center for Multiple Sclerosis Site Number : 8400147 Columbus Ohio
United States The Ohio State University Wexner Medical Center Site Number : 8400150 Columbus Ohio
United States University of Colorado Site Number : 8400012 Denver Colorado
United States Wayne State University Site Number : 8400046 Detroit Michigan
United States Duke Neurological Disorders Clinic Site Number : 8400098 Durham North Carolina
United States Michigan Institute For Neurological Disorders Site Number : 8400058 Farmington Hills Michigan
United States Advanced Neurosciences Research Site Number : 8400025 Fort Collins Colorado
United States Advanced Neuroscience Center Site Number : 8400035 Franklin Tennessee
United States University of Florida, Fixel Center for Neurology Site Number : 8400159 Gainesville Florida
United States Mountain View Clinical Research Site Number : 8400024 Greer South Carolina
United States Hackensack University Hospital Site Number : 8400047 Hackensack New Jersey
United States Hawaii Pacific Neuroscience Site Number : 8400103 Honolulu Hawaii
United States Saint Luke's Hospital Site Number : 8400153 Kansas City Missouri
United States Mt Olympus Medical Research Site Number : 8400163 Katy Texas
United States UC San Diego ACTRI Site Number : 8400101 La Jolla California
United States University of Kentucky Site Number : 8400106 Lexington Kentucky
United States Collaborative Neuroscience Research Site Number : 8400045 Los Alamitos California
United States Multiple Sclerosis Center Site Number : 8400143 Los Angeles California
United States International Neurorehabilitation Institute Site Number : 8400034 Lutherville Maryland
United States Neurology Associates, PA Site Number : 8400004 Maitland Florida
United States Methodist Hospital Site Number : 8400164 Merrillville Indiana
United States Medical College of Wisconsin Site Number : 8400028 Milwaukee Wisconsin
United States Wheaton Franciscan Healthcare Site Number : 8400022 Milwaukee Wisconsin
United States Ochsner Baptist Clinical Trials Unit (CTU) Site Number : 8400107 New Orleans Louisiana
United States Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038 New York New York
United States Multiple Sclerosis Center of California Site Number : 8400135 Newport Beach California
United States Consultants In Neurology Site Number : 8400011 Northbrook Illinois
United States University Of Nebraska Site Number : 8400129 Omaha Nebraska
United States College Park Family Care Center Site Number : 8400044 Overland Park Kansas
United States The Memorial Hospital Site Number : 8400033 Owosso Michigan
United States Sharlin Health & Neurology Site Number : 8400093 Ozark Missouri
United States SC3 Research - Pasadena Site Number : 8400070 Pasadena California
United States Jefferson Neurology Associates Site Number : 8400016 Philadelphia Pennsylvania
United States Providence Multiple Sclerosis Center Site Number : 8400020 Portland Oregon
United States Meridian Clinical Research, LLC Site Number : 8400005 Raleigh North Carolina
United States Mayo Clinic Site Number : 8400111 Rochester Minnesota
United States Neurology Center of San Antonio Site Number : 8400036 San Antonio Texas
United States University of San Francisco, Sandler Neurosciences Center Site Number : 8400137 San Francisco California
United States Velocity Clinical Research Site Number : 8400003 Savannah Georgia
United States Prairie Education and Research Cooperative Site Number : 8400071 Springfield Illinois
United States Neurology Associates of Stony Brook Site Number : 8400042 Stony Brook New York
United States University of South Florida Site Number : 8400006 Tampa Florida
United States Harbor UCLA Site Number : 8400088 Torrance California
United States Atrium Health Wake Forest Baptist Site Number : 8400116 Winston-Salem North Carolina
United States University of Massachusetts Site Number : 8400014 Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Georgia,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Latvia,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3-month composite Confirmed Disability Progression (cCDP) Time to onset of 3-month cCDP defined as follows:
Increase over at least 3 months of =1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is =5.5, or =0.5 points when the baseline EDSS score is >5.5, or =20% from the baseline T25-FW, or =20% from the baseline 9-HPT
Up to approximately 60 months
Secondary 6-month Confirmed Disability Progression (CDP) Time to onset of 6-month CDP as assessed by EDSS score Up to approximately 60 months
Secondary 6-month composite Confirmed Disability Progression (cCDP) Time to onset of 6-month cCDP Up to approximately 60 months
Secondary Change in T2 hyperintense lesions by MRI Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS) From screening MRI to approximately 60 months
Secondary Time to onset of confirmed disability improvement (CDI) Time to onset of CDI defined as =1.0-point decrease on the EDSS score from baseline confirmed over at least 6 months Up to approximately 60 months
Secondary Percent change in Brain volume (BV) Percent change in brain volume (BV) as detected by brain MRI at the EOS compared to month 6 From 6 months up to approximately 60 months
Secondary Change in cognitive function as assessed by SDMT Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT) From Baseline up to approximately 60 months
Secondary Change in cognitive function as assessed by CVLT-II Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available From Baseline up to approximately 60 months
Secondary Change in Multiple Sclerosis Quality of Life Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline From Baseline up to approximately 60 months
Secondary Safety and Tolerability Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI) From screening up to approximately 60 months
Secondary Population pharmacokinetics Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12 Months 6, 9 and 12
Secondary Change in plasma neurofilament light chain (NfL) Change in NfL levels from at the EOS compared to baseline From Baseline up to approximately 60 months
Secondary Change in lymphocyte phenotype subsets Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants From Baseline up to approximately 60 months
Secondary Changes in serum Immunoglobulin level Changes in serum Immunoglobulin level at the EOS compared to baseline From Baseline up to approximately 60 months
Secondary Change in serum chitinase-3 like protein 1 (Chi3L1) Change in serum Chi3L1 at EOS compared to baseline From Baseline up to approximately 60 months
See also
  Status Clinical Trial Phase
Completed NCT02549703 - Mitochondrial Dysfunction and Disease Progression
Recruiting NCT02273635 - Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS Phase 1/Phase 2
Withdrawn NCT05029609 - Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS Phase 1
Terminated NCT03283826 - Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis Phase 1/Phase 2
Active, not recruiting NCT05974852 - Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS
Active, not recruiting NCT05974839 - Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)
Recruiting NCT04977622 - Gray Matter Demyelination in Primary Progressive MS at 7T
Recruiting NCT05893225 - Metformin Add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination And Neurodegeneration Phase 2
Completed NCT03094364 - Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis N/A
Completed NCT02253264 - A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients Phase 1
Recruiting NCT03691077 - Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714 Phase 3
Completed NCT00950248 - Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) Phase 1/Phase 2
Active, not recruiting NCT05232825 - A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis Phase 3
Recruiting NCT05229861 - The Influence of HIIT Versus MCT on Cardiorespiratory Fitness in PPMS N/A
Completed NCT01077466 - Natalizumab Treatment of Progressive Multiple Sclerosis Phase 2
Completed NCT01854359 - Idebenone for Primary Progressive Multiple Sclerosis Phase 1/Phase 2
Completed NCT03493841 - Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis Phase 1
Active, not recruiting NCT03562975 - Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus
Completed NCT00731692 - FTY720 in Patients With Primary Progressive Multiple Sclerosis Phase 3
Recruiting NCT04943289 - Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis Phase 1