Phase
Condition
Multiple Sclerosis
Neurologic Disorders
Memory Loss
Treatment
Teriflunomide
Teriflunomide HMR1726
Placebo to match Teriflunomide
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria :
The participant must be 18 to 55 years of age, inclusive, at the time of signing theinformed consent
The participant must have been diagnosed with RMS according to the 2017 revision ofthe McDonald diagnostic criteria
The participant has an expanded disability status scale (EDSS) score ≤5.5 at thefirst 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 regulationsregarding the methods of contraception for those participating in clinical studies
Male participants are eligible to participate if they agree to the following duringthe intervention period and until accelerated elimination procedure:
Refrain from donating sperm
Plus either:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception/barrier as detailed below:
Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions apply:
Is not a WOCBP OR
Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency,during the intervention period and until accelerated elimination procedure iscompleted (or for at least 10 days after the last dose of SAR442168, if thecase was unblinded)
A WOCBP must have a negative highly sensitive pregnancy test at screening and within 24hours before the first dose of study intervention.
If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serumpregnancy test is required. In such cases, the participant must be excluded fromparticipation if the serum pregnancy result is positive.
The Investigator is responsible for review of medical history, menstrual history,and recent sexual activity to decrease the risk for inclusion of a woman with anearly undetected pregnancy.
The participant must have given written informed consent prior to undertaking anystudy related procedure. This includes consent to comply with the requirements andrestrictions listed in the informed consent form (ICF) and in this protocol. Incountries where the legal age of maturity is greater than 18 years, a specific ICFfor such legally minor participants must also be signed by the participant's legallyauthorized representative
Exclusion
Exclusion criteria:
The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or withnonrelapsing secondary progressive multiple sclerosis (SPMS)
The participant has a history of infection or may be at risk for infection includingbut not limited to: HIV, transplantation, live attenuated vaccines, progressivemultifocal leukoencephalopathy, tuberculosis, any persistent chronic or activerecurring infection
Clinically significant laboratory abnormalities (including evidence of liver injury)or electrocardiogram abnormalities at Screening.
The participant has conditions or situations that would adversely affectparticipation in this study, including but not limited to:
A short life expectancy due to pre-existing health condition(s) as determinedby their treating neurologist
Medical condition(s) or concomitant disease(s) making them nonevaluable for theprimary efficacy endpoint or that would adversely affect participation in thisstudy, as judged by the Investigator
A requirement for concomitant treatment that could bias the primary evaluation
The participant has a history of or currently has concomitant medical or clinicalconditions that would adversely affect participation in this study
At screening, the participant is positive for hepatitis B surface antigen and/orhepatitis B core antibody and/or is positive for hepatitis C antibody
The participant has any of the following:
A bleeding disorder or known platelet dysfunction at any time prior to thescreening visit
A platelet count <150 000/μL at the screening visit
The participant has a lymphocyte count below the lower limit of normal (LLN) at thescreening visit
The presence of psychiatric disturbance or substance abuse
Prior/concomitant therapy
The participant is receiving potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes
The participant is receiving anticoagulant/antiplatelet therapies
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number :0400004
Linz, 4021
AustriaSite Not Available
Investigational Site Number :1120004
Vitebsk, 210037
BelarusSite Not Available
Investigational Site Number :1120005
Vitebsk, 210009
BelarusSite Not Available
Investigational Site Number :1000002
Pleven, 5800
BulgariaSite Not Available
Investigational Site Number :1000005
Plovdiv, 4000
BulgariaSite Not Available
Investigational Site Number :1000001
Sofia, 1431
BulgariaSite Not Available
Investigational Site Number :1000004
Sofia, 1113
BulgariaSite Not Available
Investigational Site Number :1000006
Sofia, 1431
BulgariaSite Not Available
Investigational Site Number :1000008
Sofia, 1407
BulgariaSite Not Available
Investigational Site Number :1000009
Sofia, 1680
BulgariaSite Not Available
Investigational Site Number :1240016
Vancouver, British Columbia V6T 2B5
CanadaSite Not Available
Investigational Site Number :1240003
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Investigational Site Number :1240013
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Investigational Site Number :1240006
Gatineau, Quebec J8Y 1W2
CanadaSite Not Available
Investigational Site Number 1240019
West Vancouver, V7T 1C5
CanadaSite Not Available
Investigational Site Number :1560022
Baotou, 014010
ChinaSite Not Available
Investigational Site Number :1560001
Beijing, 100730
ChinaSite Not Available
Investigational Site Number :1560006
Beijing, 100034
ChinaSite Not Available
Investigational Site Number :1560009
Beijing, 100730
ChinaSite Not Available
Investigational Site Number :1560010
Beijing, 100050
ChinaSite Not Available
Investigational Site Number :1560012
Beijing, 100053
ChinaSite Not Available
Investigational Site Number :1560021
Beijing, 100853
ChinaSite Not Available
Investigational Site Number :1560023
Beijing, 100191
ChinaSite Not Available
Investigational Site Number :1560025
Beijing, 100730
ChinaSite Not Available
Investigational Site Number :1560004
Changchun, 130021
ChinaSite Not Available
Investigational Site Number :1560015
Changsha, 410008
ChinaSite Not Available
Investigational Site Number :1560005
Chengdu, 610041
ChinaSite Not Available
Investigational Site Number :1560019
Chongqing, 400016
ChinaSite Not Available
Investigational Site Number :1560035
Fuzhou, 350005
ChinaSite Not Available
Investigational Site Number :1560002
Guangzhou, 510630
ChinaSite Not Available
Investigational Site Number :1560016
Guangzhou, 510080
ChinaSite Not Available
Investigational Site Number :1560028
Guangzhou, 510515
ChinaSite Not Available
Investigational Site Number :1560027
Hohhot, 010050
ChinaSite Not Available
Investigational Site Number :1560042
Nanjing, 210029
ChinaSite Not Available
Investigational Site Number :1560044
Nanjing, 210008
ChinaSite Not Available
Investigational Site Number :1560003
Shanghai, 200040
ChinaSite Not Available
Investigational Site Number :1560018
Shenyang, 110004
ChinaSite Not Available
Investigational Site Number :1560014
Shijiazhuang, 050000
ChinaSite Not Available
Investigational Site Number :1560008
Taiyuan, 030001
ChinaSite Not Available
Investigational Site Number :1560020
Tianjin, 300052
ChinaSite Not Available
Investigational Site Number :1560011
Wuhan, 430030
ChinaSite Not Available
Investigational Site Number :1560017
Xi'an, 710038
ChinaSite Not Available
Investigational Site Number :1560033
Yinchuan, 750004
ChinaSite Not Available
Investigational Site Number :2030004
Hradec Kralove, 50005
CzechiaSite Not Available
Investigational Site Number :2030009
Pardubice, 53203
CzechiaSite Not Available
Investigational Site Number :2030003
Teplice, 415 29
CzechiaSite Not Available
Investigational Site Number :2030007
Zlin, 76275
CzechiaSite Not Available
Investigational Site Number :2080003
Aalborg, 9100
DenmarkSite Not Available
Investigational Site Number :2080001
Esbjerg, 6700
DenmarkSite Not Available
Investigational Site Number :2080005
Holstebro, 7500
DenmarkSite Not Available
Investigational Site Number 2330003
Pärnu, 80010
EstoniaSite Not Available
Investigational Site Number :2330001
Tallinn, 11315
EstoniaSite Not Available
Investigational Site Number :2330002
Tartu, 50406
EstoniaSite Not Available
Investigational Site Number :2460003
Helsinki, 00180
FinlandSite Not Available
Investigational Site Number :2460001
Tampere, 33520
FinlandSite Not Available
Investigational Site Number :2460002
Turku, 20520
FinlandSite Not Available
Investigational Site Number :2760001
Dresden, 01307
GermanySite Not Available
Investigational Site Number :2760019
Düsseldorf, 40225
GermanySite Not Available
Investigational Site Number :2760016
Hamburg, 22179
GermanySite Not Available
Investigational Site Number :2760008
Münster, 48149
GermanySite Not Available
Investigational Site Number :2760004
Rostock, 18055
GermanySite Not Available
Investigational Site Number :2760011
Ulm, 89081
GermanySite Not Available
Investigational Site Number : 3440001
Shatin, NT,
Hong KongSite Not Available
Investigational Site Number :3800002
Pozzilli, Isernia 86077
ItalySite Not Available
Investigational Site Number :3800007
Orbassano, Torino 10043
ItalySite Not Available
Investigational Site Number :3800011
Bergamo, 24127
ItalySite Not Available
Investigational Site Number :3800015
Catania, 95123
ItalySite Not Available
Investigational Site Number :3800012
Firenze, 50134
ItalySite Not Available
Investigational Site Number :3800014
Genova, 16132
ItalySite Not Available
Investigational Site Number :3800001
Milano, 20132
ItalySite Not Available
Investigational Site Number :3800010
Milano, 20133
ItalySite Not Available
Investigational Site Number :3800003
Napoli, 80131
ItalySite Not Available
Investigational Site Number :3800006
Napoli, 80131
ItalySite Not Available
Investigational Site Number :3800008
Pavia, 27100
ItalySite Not Available
Investigational Site Number :3800005
Roma, 00152
ItalySite Not Available
Investigational Site Number :3800009
Roma, 00168
ItalySite Not Available
Investigational Site Number :3800013
Roma, 00189
ItalySite Not Available
Investigational Site Number :3920016
Chiba-shi, Chiba 260-8677
JapanSite Not Available
Investigational Site Number :3920008
Koriyama-shi, Fukushima 963-8052
JapanSite Not Available
Southern Tohoku medical clinic 7-161, Yatsuyamada, Koriyama-shi, Fukushima_Investigational Site Number :3920008
Koriyama-shi, Fukushima 963-8052
JapanSite Not Available
Investigational Site Number :3920012
Tsukuba-shi, Ibaraki 305-0005
JapanSite Not Available
Investigational Site Number :3920022
Morioka-shi, Iwate 020-8505
JapanSite Not Available
Investigational Site Number :3920005
Niigata-shi, Niigata 951-8520
JapanSite Not Available
Investigational Site Number :3920004
Moriguchi-shi, Osaka 570-8507
JapanSite Not Available
Investigational Site Number :3920001
Osaka-shi, Osaka 556-0016
JapanSite Not Available
Investigational Site Number :3920018
Kawagoe-shi, Saitama 350-8550
JapanSite Not Available
Investigational Site Number :3920014
Bunkyo-ku, Tokyo 113-8431
JapanSite Not Available
Investigational Site Number :3920003
Kodaira-shi, Tokyo 187-8551
JapanSite Not Available
Investigational Site Number :3920010
Ota-ku, Tokyo 146-0065
JapanSite Not Available
Investigational Site Number :3920013
Shinjuku-ku, Tokyo 162-8666
JapanSite Not Available
Investigational Site Number :3920009
Ube-shi, Yamaguchi 755-8505
JapanSite Not Available
Investigational Site Number :3920023
Sagamihara-shi, 252-0392
JapanSite Not Available
NHO Sagamihara National Hospital Minami-ku Sakuradai 18-1, Sagamihara-shi, Kanagawa-ken_Investigational Site Number :3920023
Sagamihara-shi, 252-0392
JapanSite Not Available
Investigational Site Number :4400003
Kaunas, 50161
LithuaniaSite Not Available
Investigational Site Number :4400002
Klaipeda, 92288
LithuaniaSite Not Available
Investigational Site Number :4400004
Siauliai, LT-76231
LithuaniaSite Not Available
Investigational Site Number :4400001
Vilnius, 08661
LithuaniaSite Not Available
Investigational Site Number :4840002
Ciudad de Mexico, 03100
MexicoSite Not Available
Investigational Site Number :4840001
Mexico, 06700
MexicoSite Not Available
Investigational Site Number :4840002
Mexico, 03100
MexicoSite Not Available
Investigational Site Number :4840003
Veracruz, 91910
MexicoSite Not Available
Investigational Site Number :6160003
Bydgoszcz, Kujawsko-pomorskie 85-796
PolandSite Not Available
Investigational Site Number :6160005
Warszawa, Mazowieckie 01-211
PolandSite Not Available
Investigational Site Number :6160006
Warszawa, Mazowieckie 01-684
PolandSite Not Available
Investigational Site Number :6160009
Glogow Mlp., Podkarpackie 36-060
PolandSite Not Available
Investigational Site Number :6160002
Katowice, Slaskie 40-571
PolandSite Not Available
Investigational Site Number :6160004
Katowice, Slaskie 40-686
PolandSite Not Available
Investigational Site Number :6160008
Plewiska, Wielkopolskie 62-064
PolandSite Not Available
Investigational Site Number :6160001
Lodz, 90-549
PolandSite Not Available
Investigational Site Number :6420015
Brasov, 500283
RomaniaSite Not Available
Investigational Site Number :6420008
Bucuresti, 022328
RomaniaSite Not Available
Investigational Site Number :6420004
Campulung, 115100
RomaniaSite Not Available
Investigational Site Number :6420003
Constanta, 900123
RomaniaSite Not Available
Investigational Site Number :6420010
Oradea, 410169
RomaniaSite Not Available
Investigational Site Number :6420005
Sibiu, 550052
RomaniaSite Not Available
Investigational Site Number :6420001
Targu Mures, 540136
RomaniaSite Not Available
Investigational Site Number :6420002
Timisoara, 300736
RomaniaSite Not Available
Investigational Site Number :6430014
Krasnoyarsk, 660029
Russian FederationSite Not Available
Investigational Site Number :6430002
Moscow, 125367
Russian FederationSite Not Available
Investigational Site Number :6430008
Moscow, 129128
Russian FederationSite Not Available
Investigational Site Number :6430003
Nizhny Novgorod, 603155
Russian FederationSite Not Available
Investigational Site Number :6430011
Nizhny Novgorod, 603137
Russian FederationSite Not Available
Investigational Site Number :6430007
Pyatigorsk, 357538
Russian FederationSite Not Available
Investigational Site Number :6430012
Rostov-on-Don, 344022
Russian FederationSite Not Available
Investigational Site Number :6430005
Samara, 443095
Russian FederationSite Not Available
Investigational Site Number :6430009
Smolensk, 214018
Russian FederationSite Not Available
Investigational Site Number :6430001
St-Petersburg, 194044
Russian FederationSite Not Available
Investigational Site Number :6430006
Tyumen, 625000
Russian FederationSite Not Available
Investigational Site Number :6430004
Ufa, 450005
Russian FederationSite Not Available
Investigational Site Number :7240003
Sevilla, Andalucia 41009
SpainSite Not Available
Investigational Site Number :7240009
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Investigational Site Number :7240001
Pozuelo De Alarcón, Madrid 28223
SpainSite Not Available
Investigational Site Number :7240008
Donostia, Pais Vasco 20014
SpainSite Not Available
Investigational Site Number :7240004
Córdoba, 14004
SpainSite Not Available
Investigational Site Number :7240006
Murcia, 30120
SpainSite Not Available
Investigational Site Number :7240005
Málaga, 29010
SpainSite Not Available
Investigational Site Number :7240007
Valencia, 46026
SpainSite Not Available
Investigational Site Number :7520001
Göteborg, 413 45
SwedenSite Not Available
Investigational Site Number :7520002
Stockholm, 113 65
SwedenSite Not Available
Investigational Site Number :1580007
Hsinchu City, 30059
TaiwanSite Not Available
Investigational Site Number :1580005
Kaohsiung, 833
TaiwanSite Not Available
Investigational Site Number :1580003
Taichung, 402
TaiwanSite Not Available
Investigational Site Number :1580002
Taipei, 112
TaiwanSite Not Available
Investigational Site Number :1580006
Taoyuang, 333
TaiwanSite Not Available
Investigational Site Number 7920002
Cerrahpasa / Istanbul, 34098
TurkeySite Not Available
Investigational Site Number :7920005
Eskisehir,
TurkeySite Not Available
Investigational Site Number :7920011
Hatay,
TurkeySite Not Available
Investigational Site Number :7920002
Istanbul, 34098
TurkeySite Not Available
Investigational Site Number :7920003
Istanbul,
TurkeySite Not Available
Investigational Site Number :7920007
Istanbul, 34785
TurkeySite Not Available
Investigational Site Number :7920009
Istanbul, 34688
TurkeySite Not Available
Investigational Site Number :7920008
Izmir, 35100
TurkeySite Not Available
Investigational Site Number :7920010
Izmir,
TurkeySite Not Available
Investigational Site Number :7920001
Kocaeli, 41380
TurkeySite Not Available
Investigational Site Number :7920006
Mersin, 33070
TurkeySite Not Available
Investigational Site Number :8040011
Ivano-Frankivsk, 76493
UkraineSite Not Available
Investigational Site Number :8040013
Kharkiv, 61103
UkraineSite Not Available
Investigational Site Number :8040016
Kharkiv, 61068
UkraineSite Not Available
Investigational Site Number :8040008
Kherson, 73000
UkraineSite Not Available
Investigational Site Number :8040014
Kyiv, 03115
UkraineSite Not Available
Investigational Site Number :8040010
Lutsk, 43005
UkraineSite Not Available
Investigational Site Number :8040001
Lviv, 79010
UkraineSite Not Available
Investigational Site Number :8040009
Odesa, 65025
UkraineSite Not Available
Investigational Site Number :8040012
Zhytormyr, 10002
UkraineSite Not Available
University of Alabama MS Center-Site Number:8400013
Birmingham, Alabama 35233
United StatesSite Not Available
University of San Francisco, Sandler Neurosciences Center-Site Number:8400137
San Francisco, California 94158
United StatesSite Not Available
University of Colorado-Site Number:8400012
Aurora, Colorado 80045
United StatesSite Not Available
Georgetown University Medical Center-Site Number:8400119
Washington, District of Columbia 20007
United StatesSite Not Available
Beth Israel Deaconess Medical Center-Site Number:8400064
Fort Myers, Florida 33919
United StatesSite Not Available
Axiom Clinical Research of Florida-Site Number:8400001
Tampa, Florida 33609-4052
United StatesSite Not Available
University of South Florida-Site Number:8400006
Tampa, Florida 33612
United StatesSite Not Available
Meridian Clinical Research-Site Number:8400003
Savannah, Georgia 31406
United StatesSite Not Available
Consultants In Neurology-Site Number:8400011
Northbrook, Illinois 60062
United StatesSite Not Available
Tufts Medical Center-Site Number:8400072
Boston, Massachusetts 02111
United StatesSite Not Available
Michigan Institute For Neurological Disorders-Site Number:8400058
Farmington Hills, Michigan 48334
United StatesSite Not Available
The Memorial Hospital-Site Number:8400033
Owosso, Michigan 48867
United StatesSite Not Available
Sharlin Health & Neurology-Site Number:8400093
Ozark, Missouri 65721
United StatesSite Not Available
Missouri Baptist Medical Center-Site Number:8400019
Saint Louis, Missouri 63131
United StatesSite Not Available
Meridian Clinical Research, LLC-Site Number:8400005
Raleigh, North Carolina 27607
United StatesSite Not Available
Wake Forest University Baptist Medical Center-Site Number:8400116
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Optimed Research, LTD-Site Number:8400147
Columbus, Ohio 43235
United StatesSite Not Available
The Ohio State University Wexner Medical Center-Site Number:8400150
Columbus, Ohio 43221
United StatesSite Not Available
Columbus Neuroscience-Site Number:8400010
Westerville, Ohio 40382
United StatesSite Not Available
Oklahoma Medical Research Foundation-Site Number:8400018
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Providence Multiple Sclerosis Center-Site Number:8400020
Portland, Oregon 97225
United StatesSite Not Available
University of Texas Southwestern Medical Center-Site Number:8400077
Dallas, Texas 75390
United StatesSite Not Available
Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121
Seattle, Washington 98122
United StatesSite Not Available
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