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GEMINI 1: Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

Sponsor
Sanofi (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04410978
Collaborator
(none)
900
Enrollment
178
Locations
2
Arms
38.2
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

Secondary Objective:

To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

Condition or Disease Intervention/Treatment Phase
  • Drug: Tolebrutinib
  • Drug: Teriflunomide HMR1726
  • Drug: Placebo to match Tolebrutinib
  • Drug: Placebo to match Teriflunomide
 Phase 3

Detailed Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Actual Study Start Date :
Jun 30, 2020
Anticipated Primary Completion Date :
Sep 6, 2023
Anticipated Study Completion Date :
Sep 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAR442168

Dose 1 of oral SAR442168 + placebo to match the teriflunomide tablet once daily

Drug: Tolebrutinib
Pharmaceutical form: Tablet Route of administration: Oral
Other Names:
  • SAR442168

    • Drug: Placebo to match Teriflunomide
    Pharmaceutical form: Tablet Route of administration: Oral
    Active Comparator: Teriflunomide

    Oral 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily

    Drug: Teriflunomide HMR1726
    Pharmaceutical form: Tablet Route of administration: Oral

    Drug: Placebo to match Tolebrutinib
    Pharmaceutical form: Tablet Route of administration: Oral

    Outcome Measures

    Primary Outcome Measures

    1. Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses [Up to approximately 36 months]

      Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses

    Secondary Outcome Measures

    1. Time to onset of confirmed disability worsening confirmed over at least 6 months [Up to approximately 36 months]

      Time to onset of confirmed disability worsening (CDW), confirmed over at least 6 months, defined as follows: increase of ≥1.5 points from the baseline expanded disability status scale (EDSS) score when the baseline score is 0 OR increase of ≥1.0 point from the baseline EDSS score when the baseline score is 0.5 to ≤5.5 OR increase of ≥0.5 point from the baseline EDSS score when the baseline score is >5.5 - 5.

    2. Time to onset of CDW, assessed by the EDSS score and confirmed over at least 3 months [Up to approximately 36 months]

    3. Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from Month 6 through the end of study (EOS) [From 6 months up to approximately 36 months]

    4. Total of Gd-enhancing T1 hyperintense lesions as detected by MRI from 6 months through the EOS [From 6 months up to approximately 36 months]

    5. Change in cognitive function [From Baseline up to approximately 36 months]

      Change in cognitive function from baseline to the end of study (EOS) as assessed by SDMT and by CVLT-II where available

    6. Time to confirmed disability improvement [From Baseline up to approximately 36 months]

      Time to confirmed disability improvement (CDI), defined as a ≥1.0 point decrease on the EDSS from the baseline EDSS score confirmed over at least 6 months

    7. Percent Change in Brain volume loss (BVL) [From 6 months up to approximately 36 months]

      Brain volume loss (BVL) rate as detected by brain MRI from Month 6 to the EOS

    8. Change in Multiple Sclerosis Quality of Life [From Baseline up to approximately 36 months]

      Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS

    9. Number of participants with adverse events A(Es) leading to permanent study intervention discontinuation, and adverse events of special interest (AESI) [From screening until end of study approximately 36 months]

    10. Population Pharmacokinetics - Concentration SAR442168 and relevant metabolites at 6 months [6 Months]

      Plasma concentration of SAR442168 (population PK assessment) at 6 Months

    11. Population Pharmacokinetics Concentration of SAR442168 and relevant metabolites at 9 Months [9 Months]

      Plasma concentration of SAR442168 (population PK assessment) at 9 Months

    12. Population Pharmacokinetics - Concentration of SAR442168 and relevant metabolites at 12 Months [12 Months]

      Plasma concentration of SAR442168 (population PK assessment) at 12 Months

    13. Change in plasma NfL [From Baseline until end of study approximately 36 months]

      Change in plasma neurofilament light chain (NfL) levels at the EOS compared to baseline

    14. Change in lymphocyte Phenotype [From Baseline until end of study approximately 36 months]

      Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants

    15. Changes in plasma Immunoglobulin levels [From Baseline until end of study (up to 36 months)]

      Changes in serum immunoglobulin level at the EOS compared to baseline

    16. Change in CHI3L1 levels [From Baseline until end of study approximately 36 months]

      Change in serum Chi3L1 levels at the EOS compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria :

    • The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent

    • The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria

    • The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first 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

    • Male participants are eligible to participate if they agree to the following during the 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 or breastfeeding, 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 is completed (or for at least 10 days after the last dose of SAR442168, if the case 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 serum pregnancy test is required. In such cases, the participant must be excluded from participation 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 an early undetected pregnancy.

    • The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participant's legally authorized representative

    Exclusion criteria:

    • The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (SPMS)

    • The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent chronic or active recurring infection

    • Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.

    • The participant has conditions or situations that would adversely affect participation in this study, including but not limited to:

    • A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist

    • Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, 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 clinical conditions that would adversely affect participation in this study

    • At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis 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 the screening 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 the screening 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama MS Center-Site Number:8400013 Birmingham Alabama United States 35233
    2 University of San Francisco, Sandler Neurosciences Center-Site Number:8400137 San Francisco California United States 94158
    3 University of Colorado-Site Number:8400012 Aurora Colorado United States 80045
    4 Georgetown University Medical Center-Site Number:8400119 Washington District of Columbia United States 20007
    5 Beth Israel Deaconess Medical Center-Site Number:8400064 Fort Myers Florida United States 33919
    6 Axiom Clinical Research of Florida-Site Number:8400001 Tampa Florida United States 33609-4052
    7 University of South Florida-Site Number:8400006 Tampa Florida United States 33612
    8 Meridian Clinical Research-Site Number:8400003 Savannah Georgia United States 31406
    9 Consultants In Neurology-Site Number:8400011 Northbrook Illinois United States 60062
    10 Tufts Medical Center-Site Number:8400072 Boston Massachusetts United States 02111
    11 Michigan Institute For Neurological Disorders-Site Number:8400058 Farmington Hills Michigan United States 48334
    12 The Memorial Hospital-Site Number:8400033 Owosso Michigan United States 48867
    13 Sharlin Health & Neurology-Site Number:8400093 Ozark Missouri United States 65721
    14 Missouri Baptist Medical Center-Site Number:8400019 Saint Louis Missouri United States 63131
    15 Meridian Clinical Research, LLC-Site Number:8400005 Raleigh North Carolina United States 27607
    16 Wake Forest University Baptist Medical Center-Site Number:8400116 Winston-Salem North Carolina United States 27157
    17 The Ohio State University Wexner Medical Center-Site Number:8400150 Columbus Ohio United States 43221
    18 Optimed Research, LTD-Site Number:8400147 Columbus Ohio United States 43235
    19 Columbus Neuroscience-Site Number:8400010 Westerville Ohio United States 40382
    20 Oklahoma Medical Research Foundation-Site Number:8400018 Oklahoma City Oklahoma United States 73104
    21 Providence Multiple Sclerosis Center-Site Number:8400020 Portland Oregon United States 97225
    22 University of Texas Southwestern Medical Center-Site Number:8400077 Dallas Texas United States 75390
    23 Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121 Seattle Washington United States 98122
    24 Investigational Site Number :0400004 Linz Austria 4021
    25 Investigational Site Number :1120005 Vitebsk Belarus 210009
    26 Investigational Site Number :1120004 Vitebsk Belarus 210037
    27 Investigational Site Number :1000002 Pleven Bulgaria 5800
    28 Investigational Site Number :1000005 Plovdiv Bulgaria 4000
    29 Investigational Site Number :1000004 Sofia Bulgaria 1113
    30 Investigational Site Number :1000008 Sofia Bulgaria 1407
    31 Investigational Site Number :1000001 Sofia Bulgaria 1431
    32 Investigational Site Number :1000006 Sofia Bulgaria 1431
    33 Investigational Site Number :1000009 Sofia Bulgaria 1680
    34 Investigational Site Number :1240016 Vancouver British Columbia Canada V6T 2B5
    35 Investigational Site Number :1240003 Ottawa Ontario Canada K1H 8L6
    36 Investigational Site Number :1240013 Toronto Ontario Canada M5B 1W8
    37 Investigational Site Number :1240006 Gatineau Quebec Canada J8Y 1W2
    38 Investigational Site Number :1560022 Baotou China 014010
    39 Investigational Site Number :1560006 Beijing China 100034
    40 Investigational Site Number :1560010 Beijing China 100050
    41 Investigational Site Number :1560012 Beijing China 100053
    42 Investigational Site Number :1560023 Beijing China 100191
    43 Investigational Site Number :1560001 Beijing China 100730
    44 Investigational Site Number :1560009 Beijing China 100730
    45 Investigational Site Number :1560025 Beijing China 100730
    46 Investigational Site Number :1560021 Beijing China 100853
    47 Investigational Site Number :1560004 Changchun China 130021
    48 Investigational Site Number :1560015 Changsha China 410008
    49 Investigational Site Number :1560005 Chengdu China 610041
    50 Investigational Site Number :1560019 Chongqing China 400016
    51 Investigational Site Number :1560035 Fuzhou China 350005
    52 Investigational Site Number :1560016 Guangzhou China 510080
    53 Investigational Site Number :1560028 Guangzhou China 510515
    54 Investigational Site Number :1560002 Guangzhou China 510630
    55 Investigational Site Number :1560027 Hohhot China 010050
    56 Investigational Site Number :1560044 Nanjing China 210008
    57 Investigational Site Number :1560042 Nanjing China 210029
    58 Investigational Site Number :1560003 Shanghai China 200040
    59 Investigational Site Number :1560018 Shenyang China 110004
    60 Investigational Site Number :1560014 Shijiazhuang China 050000
    61 Investigational Site Number :1560008 Taiyuan China 030001
    62 Investigational Site Number :1560020 Tianjin China 300052
    63 Investigational Site Number :1560011 Wuhan China 430030
    64 Investigational Site Number :1560017 Xi'an China 710038
    65 Investigational Site Number :1560033 Yinchuan China 750004
    66 Investigational Site Number :2030004 Hradec Kralove Czechia 50005
    67 Investigational Site Number :2030009 Pardubice Czechia 53203
    68 Investigational Site Number :2030003 Teplice Czechia 415 29
    69 Investigational Site Number :2030007 Zlin Czechia 76275
    70 Investigational Site Number :2080001 Esbjerg Denmark 6700
    71 Investigational Site Number :2080005 Holstebro Denmark 7500
    72 Investigational Site Number :2330001 Tallinn Estonia 11315
    73 Investigational Site Number :2330002 Tartu Estonia 50406
    74 Investigational Site Number :2460003 Helsinki Finland 00180
    75 Investigational Site Number :2460001 Tampere Finland 33520
    76 Investigational Site Number :2460002 Turku Finland 20520
    77 Investigational Site Number :2760001 Dresden Germany 01307
    78 Investigational Site Number :2760019 Düsseldorf Germany 40225
    79 Investigational Site Number :2760016 Hamburg Germany 22179
    80 Investigational Site Number :2760008 Münster Germany 48149
    81 Investigational Site Number :2760004 Rostock Germany 18055
    82 Investigational Site Number :2760011 Ulm Germany 89081
    83 Investigational Site Number :3800002 Pozzilli Isernia Italy 86077
    84 Investigational Site Number :3800007 Orbassano Torino Italy 10043
    85 Investigational Site Number :3800011 Bergamo Italy 24127
    86 Investigational Site Number :3800015 Catania Italy 95123
    87 Investigational Site Number :3800012 Firenze Italy 50134
    88 Investigational Site Number :3800014 Genova Italy 16132
    89 Investigational Site Number :3800001 Milano Italy 20132
    90 Investigational Site Number :3800010 Milano Italy 20133
    91 Investigational Site Number :3800003 Napoli Italy 80131
    92 Investigational Site Number :3800006 Napoli Italy 80131
    93 Investigational Site Number :3800008 Pavia Italy 27100
    94 Investigational Site Number :3800005 Roma Italy 00152
    95 Investigational Site Number :3800009 Roma Italy 00168
    96 Investigational Site Number :3800013 Roma Italy 00189
    97 Investigational Site Number :3920016 Chiba-shi Chiba Japan 260-8677
    98 Investigational Site Number :3920008 Koriyama-shi Fukushima Japan 963-8052
    99 Investigational Site Number :3920012 Tsukuba-shi Ibaraki Japan 305-0005
    100 Investigational Site Number :3920022 Morioka-shi Iwate Japan 020-8505
    101 Investigational Site Number :3920005 Niigata-shi Niigata Japan 951-8520
    102 Investigational Site Number :3920004 Moriguchi-shi Osaka Japan 570-8507
    103 Investigational Site Number :3920001 Osaka-shi Osaka Japan 556-0016
    104 Investigational Site Number :3920018 Kawagoe-shi Saitama Japan 350-8550
    105 Investigational Site Number :3920014 Bunkyo-ku Tokyo Japan 113-8431
    106 Investigational Site Number :3920003 Kodaira-shi Tokyo Japan 187-8551
    107 Investigational Site Number :3920010 Ota-ku Tokyo Japan 146-0065
    108 Investigational Site Number :3920013 Shinjuku-ku Tokyo Japan 162-8666
    109 Investigational Site Number :3920009 Ube-shi Yamaguchi Japan 755-8505
    110 Investigational Site Number :3920023 Sagamihara-shi Japan 252-0392
    111 Investigational Site Number :4400003 Kaunas Lithuania 50161
    112 Investigational Site Number :4400002 Klaipeda Lithuania 92288
    113 Investigational Site Number :4400004 Siauliai Lithuania LT-76231
    114 Investigational Site Number :4400001 Vilnius Lithuania 08661
    115 Investigational Site Number :4840002 Mexico Mexico 03100
    116 Investigational Site Number :4840001 Mexico Mexico 06700
    117 Investigational Site Number :4840003 Veracruz Mexico 91910
    118 Investigational Site Number :6160003 Bydgoszcz Kujawsko-pomorskie Poland 85-796
    119 Investigational Site Number :6160005 Warszawa Mazowieckie Poland 01-211
    120 Investigational Site Number :6160006 Warszawa Mazowieckie Poland 01-684
    121 Investigational Site Number :6160009 Glogow Mlp. Podkarpackie Poland 36-060
    122 Investigational Site Number :6160002 Katowice Slaskie Poland 40-571
    123 Investigational Site Number :6160004 Katowice Slaskie Poland 40-686
    124 Investigational Site Number :6160008 Plewiska Wielkopolskie Poland 62-064
    125 Investigational Site Number :6160001 Lodz Poland 90-549
    126 Investigational Site Number :6420015 Brasov Romania 500283
    127 Investigational Site Number :6420008 Bucuresti Romania 022328
    128 Investigational Site Number :6420004 Campulung Romania 115100
    129 Investigational Site Number :6420003 Constanta Romania 900123
    130 Investigational Site Number :6420010 Oradea Romania 410169
    131 Investigational Site Number :6420005 Sibiu Romania 550052
    132 Investigational Site Number :6420001 Targu Mures Romania 540136
    133 Investigational Site Number :6420002 Timisoara Romania 300736
    134 Investigational Site Number :6430014 Krasnoyarsk Russian Federation 660029
    135 Investigational Site Number :6430002 Moscow Russian Federation 125367
    136 Investigational Site Number :6430008 Moscow Russian Federation 129128
    137 Investigational Site Number :6430011 Nizhny Novgorod Russian Federation 603137
    138 Investigational Site Number :6430003 Nizhny Novgorod Russian Federation 603155
    139 Investigational Site Number :6430007 Pyatigorsk Russian Federation 357538
    140 Investigational Site Number :6430012 Rostov-on-Don Russian Federation 344022
    141 Investigational Site Number :6430005 Samara Russian Federation 443095
    142 Investigational Site Number :6430009 Smolensk Russian Federation 214018
    143 Investigational Site Number :6430001 St-Petersburg Russian Federation 194044
    144 Investigational Site Number :6430006 Tyumen Russian Federation 625000
    145 Investigational Site Number :6430004 Ufa Russian Federation 450005
    146 Investigational Site Number :7240003 Sevilla Andalucia Spain 41009
    147 Investigational Site Number :7240009 Barcelona Barcelona [Barcelona] Spain 08035
    148 Investigational Site Number :7240001 Pozuelo De Alarcón Madrid Spain 28223
    149 Investigational Site Number :7240008 Donostia Pais Vasco Spain 20014
    150 Investigational Site Number :7240004 Córdoba Spain 14004
    151 Investigational Site Number :7240006 Murcia Spain 30120
    152 Investigational Site Number :7240005 Málaga Spain 29010
    153 Investigational Site Number :7240007 Valencia Spain 46026
    154 Investigational Site Number :7520001 Göteborg Sweden 413 45
    155 Investigational Site Number :7520002 Stockholm Sweden 113 65
    156 Investigational Site Number :1580007 Hsinchu City Taiwan 30059
    157 Investigational Site Number :1580005 Kaohsiung Taiwan 833
    158 Investigational Site Number :1580003 Taichung Taiwan 402
    159 Investigational Site Number :1580002 Taipei Taiwan 112
    160 Investigational Site Number :1580006 Taoyuang Taiwan 333
    161 Investigational Site Number :7920005 Eskisehir Turkey
    162 Investigational Site Number :7920011 Hatay Turkey
    163 Investigational Site Number :7920002 Istanbul Turkey 34098
    164 Investigational Site Number :7920009 Istanbul Turkey 34688
    165 Investigational Site Number :7920007 Istanbul Turkey 34785
    166 Investigational Site Number :7920003 Istanbul Turkey
    167 Investigational Site Number :7920008 Izmir Turkey 35100
    168 Investigational Site Number :7920010 Izmir Turkey
    169 Investigational Site Number :7920001 Kocaeli Turkey 41380
    170 Investigational Site Number :7920006 Mersin Turkey 33070
    171 Investigational Site Number :8040011 Ivano-Frankivsk Ukraine 76493
    172 Investigational Site Number :8040016 Kharkiv Ukraine 61068
    173 Investigational Site Number :8040013 Kharkiv Ukraine 61103
    174 Investigational Site Number :8040008 Kherson Ukraine 73000
    175 Investigational Site Number :8040014 Kyiv Ukraine 03115
    176 Investigational Site Number :8040010 Lutsk Ukraine 43005
    177 Investigational Site Number :8040001 Lviv Ukraine 79010
    178 Investigational Site Number :8040009 Odesa Ukraine 65025

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04964791
    Other Study ID Numbers:
    • EFC16033
    • U1111-1238-1418
    • NCT04964791
    First Posted:
    Jun 1, 2020
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Teriflunomide

    Study Results

    No Results Posted as of Aug 8, 2022