| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1238-1418 | Registry Identifier | ICTRP | |
| 2020-000637-41 | EudraCT Number |
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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
This was an event-driven (6-month confirmed disability worsening [CDW]) trial with a variable treatment duration (end-of-study [EOS] duration: up to approximately 48 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR442168 | Experimental | 60 mg oral SAR442168 + placebo to match the teriflunomide tablet once daily |
|
| Teriflunomide | Active Comparator | 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolebrutinib | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses | Multiple sclerosis (MS) relapse was defined as a monophasic, acute or subacute onset of new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for >=24 hours with or without recovery, present at normal body temperature, and preceded by >=30 days of clinical stability. | Baseline (Day 1) to approximately 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of 6-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 6-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 6 months that was not attributable to another etiology. |
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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:
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:
Plus either:
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:
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, 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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama MS Center-Site Number:8400013 | Birmingham | Alabama | 35233 | United States | ||
| University of San Francisco, Sandler Neurosciences Center-Site Number:8400137 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40202623 | Derived | Oh J, Arnold DL, Cree BAC, Ionete C, Kim HJ, Sormani MP, Syed S, Chen Y, Maxwell CR, Benoit P, Turner TJ, Wallstroem E, Wiendl H; Tolebrutinib Phase 3 GEMINI 1 and 2 Trial Group. Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2025 May 15;392(19):1893-1904. doi: 10.1056/NEJMoa2415985. Epub 2025 Apr 8. |
| Label | URL |
|---|---|
| EFC16033 Plain language Results Summary | View source |
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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
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A total of 974 participants were randomized in this study in a 1:1 ratio to either teriflunomide 14 milligrams (mg) or tolebrutinib 60 mg group. This was an event-driven (6-month confirmed disability worsening [CDW]) trial with a variable treatment duration (end-of-study [EOS] duration: up to approximately 48 months).
This study was conducted at 162 sites in 24 countries. A total of 1152 participants were screened from 30-Jun-2020 to 04-Aug-2022, of which 178 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally once daily (QD) along with a placebo matched to tolebrutinib orally QD up to approximately 47 months. |
| FG001 | Tolebrutinib 60 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2023 | Jun 3, 2025 |
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| Teriflunomide | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Placebo to match Tolebrutinib | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Placebo to match Teriflunomide | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Baseline (Day 1) to approximately 48 months |
| Time to Onset of 3-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 3-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 3 months that was not attributable to another etiology. | Baseline (Day 1) to approximately 48 months |
| Mean Number of New and/or Enlarging T2-Hyperintense Lesions Per Year | Magnetic resonance imaging (MRI) of the brain was performed to identify number of new and/or enlarging T2-hyperintense lesions defined as the sum of the individual number of new and/or enlarging T2 lesions starting from baseline up to and including the EOS visit. | Baseline (Day 1) to approximately 48 months |
| Mean Number of New Gadolinium-Enhancing T1-Hyperintense Lesions Per Scan | MRI of the brain was performed to identify number of new Gd-enhancing T1-hyperintense lesions defined as the sum of the individual number of new Gd- enhancing T1-hyperintense lesions starting from baseline up to and including the EOS visit. | Baseline (Day 1) to approximately 48 months |
| Change From Baseline in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) at EOS | The SDMT was used to assess processing speed, divided attention, visual scanning, tracking and motor speed. It involved a simple substitution task using a reference key. The number of correct substitutions and number of items completed within a 90 second interval (maximum 110 seconds) were recorded. A decrease of 4 points from baseline on the SDMT was considered meaningful worsening. The score was the number of correctly coded items from 0-110 in 90 seconds; higher scores indicating a better outcome. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test Second Edition (CVLT-II) at EOS | The CVLT-II was a verbal learning and memory test consisting of recall and recognition of a list of 16 words. For each assessment, 5 trials were completed. Total Correct Recall Trials 1-5 was scaled to a normalized T-score metric, which had a mean of 50 and standard deviation of 10, the maximum possible score was 80 and a minimum was 0. Higher values indicated improved cognitive function. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Time to Onset of 6-Month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. CDI was defined as a decrease of >=1 point from baseline in the EDSS score lasting at least 6 months. | Baseline (Day 1) to approximately 48 months |
| Percent Change in Brain Volume Loss at EOS Compared to Month 6 | MRI of the brain was performed at the specified timepoints to detect the changes in brain volume loss. | Month 6 to EOS (up to approximately 48 months) |
| Change From Baseline in Multiple Sclerosis Quality of Life 54 (MSQoL-54) Questionnaire Score at EOS | MSQoL-54 was standardized instrument comprising generic and MS-specific items. This 54-item instrument generated 12 subscales and 2 single-item measures (satisfaction with sexual function [1 item]; change in health [1 item]). 12 subscales were: a: physical health (10 items), b: health perceptions (5 items), c: energy (5 items), d: role limit physical (4 items), e: sexual function (4 items), f: pain (3 items), g: social function (3 items), h: health distress (4 items), i: overall quality of life (2 items), j: emotional well-being (5 items), k: role limitations emotional (3 items) and l: cognitive function (4 items). Physical and mental health composite score were calculated as weighted sum of 'a to h' and 'i to l' subscales respectively. Each composite score was transformed linearly to common 0 (worst) to 100 (best) score range; higher score indicated improved quality of life. Baseline was defined as last available value prior to first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), TEAEs Leading to Permanent Study Intervention Discontinuation and Treatment-emergent Adverse Events of Special Interest (AESIs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months |
| Maximum Observed Plasma Concentration (Cmax) of Tolebrutinib and M2 Metabolite | Blood samples were collected at specified timepoints to assess Cmax of tolebrutinib and M2 metabolite using population pharmacokinetic (PK) model. | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 |
| Time to Maximum Observed Plasma Concentration (Tmax) of Tolebrutinib and M2 Metabolite | Blood samples were collected at specified timepoints to assess Tmax of tolebrutinib and M2 metabolite using population PK model. | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 |
| Area Under the Plasma Concentration-time Curve Over the Last 24-hours Dosing Interval (AUC0-24) of Tolebrutinib and M2 Metabolite | Blood samples were collected at specified timepoints to assess AUC0-24 of tolebrutinib and M2 metabolite using population PK model. | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 |
| Change From Baseline in Plasma Neurofilament Light Chain (NfL) and Serum Chitinase-3 Like Protein-1 (Chi3L1) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in NfL and Chi3L1. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Change From Baseline in Cluster of Differentiation (CD)19+ B Cells at EOS | Blood samples were collected at specified timepoints to assess change from baseline in CD19+ B cells. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Change From Baseline in Serum Immunoglobulin (Ig) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in IgG and IgM levels. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| San Francisco |
| California |
| 94158 |
| United States |
| University of Colorado-Site Number:8400012 | Aurora | Colorado | 80045 | United States |
| Georgetown University Medical Center-Site Number:8400119 | Washington D.C. | District of Columbia | 20007 | United States |
| Beth Israel Deaconess Medical Center-Site Number:8400064 | Fort Myers | Florida | 33919 | United States |
| Axiom Clinical Research of Florida-Site Number:8400001 | Tampa | Florida | 33609-4052 | United States |
| University of South Florida-Site Number:8400006 | Tampa | Florida | 33612 | United States |
| Meridian Clinical Research-Site Number:8400003 | Savannah | Georgia | 31406 | United States |
| Consultants In Neurology-Site Number:8400011 | Northbrook | Illinois | 60062 | United States |
| Tufts Medical Center-Site Number:8400072 | Boston | Massachusetts | 02111 | United States |
| Michigan Institute For Neurological Disorders-Site Number:8400058 | Farmington Hills | Michigan | 48334 | United States |
| The Memorial Hospital-Site Number:8400033 | Owosso | Michigan | 48867 | United States |
| Sharlin Health & Neurology-Site Number:8400093 | Ozark | Missouri | 65721 | United States |
| Missouri Baptist Medical Center-Site Number:8400019 | St Louis | Missouri | 63131 | United States |
| Meridian Clinical Research, LLC-Site Number:8400005 | Raleigh | North Carolina | 27607 | United States |
| Wake Forest University Baptist Medical Center-Site Number:8400116 | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University Wexner Medical Center-Site Number:8400150 | Columbus | Ohio | 43221 | United States |
| Optimed Research, LTD-Site Number:8400147 | Columbus | Ohio | 43235 | United States |
| Columbus Neuroscience-Site Number:8400010 | Westerville | Ohio | 40382 | United States |
| Oklahoma Medical Research Foundation-Site Number:8400018 | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Multiple Sclerosis Center-Site Number:8400020 | Portland | Oregon | 97225 | United States |
| University of Texas Southwestern Medical Center-Site Number:8400077 | Dallas | Texas | 75390 | United States |
| Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121 | Seattle | Washington | 98122 | United States |
| Investigational Site Number :0400004 | Linz | 4021 | Austria |
| Investigational Site Number :1120005 | Vitebsk | 210009 | Belarus |
| Investigational Site Number :1120004 | Vitebsk | 210037 | Belarus |
| Investigational Site Number :1000002 | Pleven | 5800 | Bulgaria |
| Investigational Site Number :1000005 | Plovdiv | 4000 | Bulgaria |
| Investigational Site Number :1000004 | Sofia | 1113 | Bulgaria |
| Investigational Site Number :1000008 | Sofia | 1407 | Bulgaria |
| Investigational Site Number :1000001 | Sofia | 1431 | Bulgaria |
| Investigational Site Number :1000006 | Sofia | 1431 | Bulgaria |
| Investigational Site Number :1000009 | Sofia | 1680 | Bulgaria |
| Investigational Site Number :1240016 | Vancouver | British Columbia | V6T 2B5 | Canada |
| Investigational Site Number :1240003 | Ottawa | Ontario | K1H 8L6 | Canada |
| Investigational Site Number :1240013 | Toronto | Ontario | M5B 1W8 | Canada |
| Investigational Site Number :1240006 | Gatineau | Quebec | J8Y 1W2 | Canada |
| Investigational Site Number :1560022 | Baotou | 014010 | China |
| Investigational Site Number :1560006 | Beijing | 100034 | China |
| Investigational Site Number :1560010 | Beijing | 100050 | China |
| Investigational Site Number :1560012 | Beijing | 100053 | China |
| Investigational Site Number :1560023 | Beijing | 100191 | China |
| Investigational Site Number :1560001 | Beijing | 100730 | China |
| Investigational Site Number :1560009 | Beijing | 100730 | China |
| Investigational Site Number :1560025 | Beijing | 100730 | China |
| Investigational Site Number :1560021 | Beijing | 100853 | China |
| Investigational Site Number :1560004 | Changchun | 130021 | China |
| Investigational Site Number :1560015 | Changsha | 410008 | China |
| Investigational Site Number :1560005 | Chengdu | 610041 | China |
| Investigational Site Number :1560019 | Chongqing | 400016 | China |
| Investigational Site Number :1560035 | Fuzhou | 350005 | China |
| Investigational Site Number :1560016 | Guangzhou | 510080 | China |
| Investigational Site Number :1560028 | Guangzhou | 510515 | China |
| Investigational Site Number :1560002 | Guangzhou | 510630 | China |
| Investigational Site Number :1560027 | Hohhot | 010050 | China |
| Investigational Site Number :1560044 | Nanjing | 210008 | China |
| Investigational Site Number :1560042 | Nanjing | 210029 | China |
| Investigational Site Number :1560003 | Shanghai | 200040 | China |
| Investigational Site Number :1560018 | Shenyang | 110004 | China |
| Investigational Site Number :1560014 | Shijiazhuang | 050000 | China |
| Investigational Site Number :1560008 | Taiyuan | 030001 | China |
| Investigational Site Number :1560020 | Tianjin | 300052 | China |
| Investigational Site Number :1560011 | Wuhan | 430030 | China |
| Investigational Site Number :1560017 | Xi'an | 710038 | China |
| Investigational Site Number :1560033 | Yinchuan | 750004 | China |
| Investigational Site Number :2030004 | Hradec Králové | 50005 | Czechia |
| Investigational Site Number :2030009 | Pardubice | 53203 | Czechia |
| Investigational Site Number :2030003 | Teplice | 415 29 | Czechia |
| Investigational Site Number :2030007 | Zlín | 76275 | Czechia |
| Investigational Site Number :2080001 | Esbjerg | 6700 | Denmark |
| Investigational Site Number :2080005 | Holstebro | 7500 | Denmark |
| Investigational Site Number :2330001 | Tallinn | 11315 | Estonia |
| Investigational Site Number :2330002 | Tartu | 50406 | Estonia |
| Investigational Site Number :2460003 | Helsinki | 00180 | Finland |
| Investigational Site Number :2460001 | Tampere | 33520 | Finland |
| Investigational Site Number :2460002 | Turku | 20520 | Finland |
| Investigational Site Number :2760001 | Dresden | 01307 | Germany |
| Investigational Site Number :2760019 | Düsseldorf | 40225 | Germany |
| Investigational Site Number :2760016 | Hamburg | 22179 | Germany |
| Investigational Site Number :2760008 | Münster | 48149 | Germany |
| Investigational Site Number :2760004 | Rostock | 18055 | Germany |
| Investigational Site Number :2760011 | Ulm | 89081 | Germany |
| Investigational Site Number : 3440001 | Shatin, NT | Hong Kong |
| Investigational Site Number :3800002 | Pozzilli | Isernia | 86077 | Italy |
| Investigational Site Number :3800007 | Orbassano | Torino | 10043 | Italy |
| Investigational Site Number :3800011 | Bergamo | 24127 | Italy |
| Investigational Site Number :3800015 | Catania | 95123 | Italy |
| Investigational Site Number :3800012 | Florence | 50134 | Italy |
| Investigational Site Number :3800014 | Genova | 16132 | Italy |
| Investigational Site Number :3800001 | Milan | 20132 | Italy |
| Investigational Site Number :3800010 | Milan | 20133 | Italy |
| Investigational Site Number :3800003 | Naples | 80131 | Italy |
| Investigational Site Number :3800006 | Naples | 80131 | Italy |
| Investigational Site Number :3800008 | Pavia | 27100 | Italy |
| Investigational Site Number :3800005 | Roma | 00152 | Italy |
| Investigational Site Number :3800009 | Roma | 00168 | Italy |
| Investigational Site Number :3800013 | Roma | 00189 | Italy |
| Investigational Site Number :3920016 | Chiba | Chiba | 260-8677 | Japan |
| Investigational Site Number :3920008 | Koriyama-shi | Fukushima | 963-8052 | Japan |
| Investigational Site Number :3920012 | Tsukuba | Ibaraki | 305-0005 | Japan |
| Investigational Site Number :3920022 | Morioka | Iwate | 020-8505 | Japan |
| Investigational Site Number :3920005 | Niigata | Niigata | 951-8520 | Japan |
| Investigational Site Number :3920004 | Moriguchi-shi | Osaka | 570-8507 | Japan |
| Investigational Site Number :3920001 | Osaka | Osaka | 556-0016 | Japan |
| Investigational Site Number :3920018 | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Investigational Site Number :3920014 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Investigational Site Number :3920003 | Kodaira-shi | Tokyo | 187-8551 | Japan |
| Investigational Site Number :3920010 | Ōta-ku | Tokyo | 146-0065 | Japan |
| Investigational Site Number :3920013 | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Investigational Site Number :3920009 | Ube-shi | Yamaguchi | 755-8505 | Japan |
| Investigational Site Number :3920023 | Sagamihara-shi | 252-0392 | Japan |
| Investigational Site Number :4400003 | Kaunas | 50161 | Lithuania |
| Investigational Site Number :4400002 | Klaipėda | 92288 | Lithuania |
| Investigational Site Number :4400004 | Šiauliai | LT-76231 | Lithuania |
| Investigational Site Number :4400001 | Vilnius | 08661 | Lithuania |
| Investigational Site Number :4840002 | México | 03100 | Mexico |
| Investigational Site Number :4840001 | México | 06700 | Mexico |
| Investigational Site Number :4840003 | Veracruz | 91910 | Mexico |
| Investigational Site Number :6160008 | Plewiska | Greater Poland Voivodeship | 62-064 | Poland |
| Investigational Site Number :6160003 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Investigational Site Number :6160005 | Warsaw | Masovian Voivodeship | 01-211 | Poland |
| Investigational Site Number :6160006 | Warsaw | Masovian Voivodeship | 01-684 | Poland |
| Investigational Site Number :6160009 | Glogow Mlp. | Podkarpackie Voivodeship | 36-060 | Poland |
| Investigational Site Number :6160002 | Katowice | Silesian Voivodeship | 40-571 | Poland |
| Investigational Site Number :6160004 | Katowice | Silesian Voivodeship | 40-686 | Poland |
| Investigational Site Number :6160001 | Lodz | 90-549 | Poland |
| Investigational Site Number :6420015 | Brasov | 500283 | Romania |
| Investigational Site Number :6420008 | Bucharest | 022328 | Romania |
| Investigational Site Number :6420004 | Campulung Muscel | 115100 | Romania |
| Investigational Site Number :6420003 | Constanța | 900123 | Romania |
| Investigational Site Number :6420010 | Oradea | 410169 | Romania |
| Investigational Site Number :6420005 | Sibiu | 550052 | Romania |
| Investigational Site Number :6420001 | Târgu Mureş | 540136 | Romania |
| Investigational Site Number :6420002 | Timișoara | 300736 | Romania |
| Investigational Site Number :6430014 | Krasnoyarsk | 660029 | Russia |
| Investigational Site Number :6430002 | Moscow | 125367 | Russia |
| Investigational Site Number :6430008 | Moscow | 129128 | Russia |
| Investigational Site Number :6430011 | Nizhny Novgorod | 603137 | Russia |
| Investigational Site Number :6430003 | Nizhny Novgorod | 603155 | Russia |
| Investigational Site Number :6430007 | Pyatigorsk | 357538 | Russia |
| Investigational Site Number :6430012 | Rostov-on-Don | 344022 | Russia |
| Investigational Site Number :6430001 | Saint Petersburg | 194044 | Russia |
| Investigational Site Number :6430005 | Samara | 443095 | Russia |
| Investigational Site Number :6430009 | Smolensk | 214018 | Russia |
| Investigational Site Number :6430006 | Tyumen | 625000 | Russia |
| Investigational Site Number :6430004 | Ufa | 450005 | Russia |
| Investigational Site Number :7240003 | Seville | Andalusia | 41009 | Spain |
| Investigational Site Number :7240009 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number :7240008 | Donostia / San Sebastian | Basque Country | 20014 | Spain |
| Investigational Site Number :7240001 | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Investigational Site Number :7240004 | Córdoba | 14004 | Spain |
| Investigational Site Number :7240005 | Málaga | 29010 | Spain |
| Investigational Site Number :7240006 | Murcia | 30120 | Spain |
| Investigational Site Number :7240007 | Valencia | 46026 | Spain |
| Investigational Site Number :7520001 | Gothenburg | 413 45 | Sweden |
| Investigational Site Number :7520002 | Stockholm | 113 65 | Sweden |
| Investigational Site Number :1580007 | Hsinchu | 30059 | Taiwan |
| Investigational Site Number :1580005 | Kaohsiung City | 833 | Taiwan |
| Investigational Site Number :1580003 | Taichung | 402 | Taiwan |
| Investigational Site Number :1580002 | Taipei | 112 | Taiwan |
| Investigational Site Number :1580006 | Taoyuang | 333 | Taiwan |
| Investigational Site Number :7920005 | Eskişehir | Turkey (Türkiye) |
| Investigational Site Number :7920011 | Hatay | Turkey (Türkiye) |
| Investigational Site Number :7920002 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number :7920009 | Istanbul | 34688 | Turkey (Türkiye) |
| Investigational Site Number :7920007 | Istanbul | 34785 | Turkey (Türkiye) |
| Investigational Site Number :7920003 | Istanbul | Turkey (Türkiye) |
| Investigational Site Number :7920008 | Izmir | 35100 | Turkey (Türkiye) |
| Investigational Site Number :7920010 | Izmir | Turkey (Türkiye) |
| Investigational Site Number :7920001 | Kocaeli | 41380 | Turkey (Türkiye) |
| Investigational Site Number :7920006 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number :8040011 | Ivano-Frankivsk | 76493 | Ukraine |
| Investigational Site Number :8040016 | Kharkiv | 61068 | Ukraine |
| Investigational Site Number :8040013 | Kharkiv | 61103 | Ukraine |
| Investigational Site Number :8040008 | Kherson | 73000 | Ukraine |
| Investigational Site Number :8040014 | Kyiv | 03115 | Ukraine |
| Investigational Site Number :8040010 | Lutsk | 43005 | Ukraine |
| Investigational Site Number :8040001 | Lviv | 79010 | Ukraine |
| Investigational Site Number :8040009 | Odesa | 65025 | Ukraine |
Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 48 months.
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on the randomized population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally QD along with a placebo matched to tolebrutinib orally QD up to approximately 47 months. |
| BG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 48 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses | Multiple sclerosis (MS) relapse was defined as a monophasic, acute or subacute onset of new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for >=24 hours with or without recovery, present at normal body temperature, and preceded by >=30 days of clinical stability. | The intent-to-treat (ITT) population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Number | 95% Confidence Interval | relapses per participant year | Baseline (Day 1) to approximately 48 months |
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| Secondary | Time to Onset of 6-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 6-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 6 months that was not attributable to another etiology. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Median | Full Range | months | Baseline (Day 1) to approximately 48 months |
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| Secondary | Time to Onset of 3-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 3-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 3 months that was not attributable to another etiology. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Median | Full Range | months | Baseline (Day 1) to approximately 48 months |
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| Secondary | Mean Number of New and/or Enlarging T2-Hyperintense Lesions Per Year | Magnetic resonance imaging (MRI) of the brain was performed to identify number of new and/or enlarging T2-hyperintense lesions defined as the sum of the individual number of new and/or enlarging T2 lesions starting from baseline up to and including the EOS visit. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Mean | 95% Confidence Interval | number of new and or enlarging T2lesions | Baseline (Day 1) to approximately 48 months |
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| Secondary | Mean Number of New Gadolinium-Enhancing T1-Hyperintense Lesions Per Scan | MRI of the brain was performed to identify number of new Gd-enhancing T1-hyperintense lesions defined as the sum of the individual number of new Gd- enhancing T1-hyperintense lesions starting from baseline up to and including the EOS visit. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Mean | 95% Confidence Interval | number of new Gd-enhancing T1 lesions | Baseline (Day 1) to approximately 48 months |
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| Secondary | Change From Baseline in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) at EOS | The SDMT was used to assess processing speed, divided attention, visual scanning, tracking and motor speed. It involved a simple substitution task using a reference key. The number of correct substitutions and number of items completed within a 90 second interval (maximum 110 seconds) were recorded. A decrease of 4 points from baseline on the SDMT was considered meaningful worsening. The score was the number of correctly coded items from 0-110 in 90 seconds; higher scores indicating a better outcome. Baseline was defined as the last available value prior to the first dose of study intervention. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test Second Edition (CVLT-II) at EOS | The CVLT-II was a verbal learning and memory test consisting of recall and recognition of a list of 16 words. For each assessment, 5 trials were completed. Total Correct Recall Trials 1-5 was scaled to a normalized T-score metric, which had a mean of 50 and standard deviation of 10, the maximum possible score was 80 and a minimum was 0. Higher values indicated improved cognitive function. Baseline was defined as the last available value prior to the first dose of study intervention. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | T-score | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Time to Onset of 6-Month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. CDI was defined as a decrease of >=1 point from baseline in the EDSS score lasting at least 6 months. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Median | Full Range | months | Baseline (Day 1) to approximately 48 months |
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| Secondary | Percent Change in Brain Volume Loss at EOS Compared to Month 6 | MRI of the brain was performed at the specified timepoints to detect the changes in brain volume loss. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | percent change | Month 6 to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Multiple Sclerosis Quality of Life 54 (MSQoL-54) Questionnaire Score at EOS | MSQoL-54 was standardized instrument comprising generic and MS-specific items. This 54-item instrument generated 12 subscales and 2 single-item measures (satisfaction with sexual function [1 item]; change in health [1 item]). 12 subscales were: a: physical health (10 items), b: health perceptions (5 items), c: energy (5 items), d: role limit physical (4 items), e: sexual function (4 items), f: pain (3 items), g: social function (3 items), h: health distress (4 items), i: overall quality of life (2 items), j: emotional well-being (5 items), k: role limitations emotional (3 items) and l: cognitive function (4 items). Physical and mental health composite score were calculated as weighted sum of 'a to h' and 'i to l' subscales respectively. Each composite score was transformed linearly to common 0 (worst) to 100 (best) score range; higher score indicated improved quality of life. Baseline was defined as last available value prior to first dose of study intervention. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), TEAEs Leading to Permanent Study Intervention Discontinuation and Treatment-emergent Adverse Events of Special Interest (AESIs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. | Posted | Count of Participants | Participants | From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Tolebrutinib and M2 Metabolite | Blood samples were collected at specified timepoints to assess Cmax of tolebrutinib and M2 metabolite using population pharmacokinetic (PK) model. | The PK population included all participants in the safety population with at least 1 non-missing PK sample after first dose of the study intervention. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Tolebrutinib and M2 Metabolite | Blood samples were collected at specified timepoints to assess Tmax of tolebrutinib and M2 metabolite using population PK model. | The PK population included all participants in the safety population with at least 1 non-missing PK sample after first dose of the study intervention. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | hour (h) | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 |
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| Secondary | Area Under the Plasma Concentration-time Curve Over the Last 24-hours Dosing Interval (AUC0-24) of Tolebrutinib and M2 Metabolite | Blood samples were collected at specified timepoints to assess AUC0-24 of tolebrutinib and M2 metabolite using population PK model. | The PK population included all participants in the safety population with at least 1 non-missing PK sample after first dose of the study intervention. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | ng*h/mL | 30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12 |
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| Secondary | Change From Baseline in Plasma Neurofilament Light Chain (NfL) and Serum Chitinase-3 Like Protein-1 (Chi3L1) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in NfL and Chi3L1. Baseline was defined as the last available value prior to the first dose of study intervention. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Median | Inter-Quartile Range | picogram/mL | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Cluster of Differentiation (CD)19+ B Cells at EOS | Blood samples were collected at specified timepoints to assess change from baseline in CD19+ B cells. Baseline was defined as the last available value prior to the first dose of study intervention. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints are reported. | Posted | Median | Inter-Quartile Range | cells/microliter | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Serum Immunoglobulin (Ig) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in IgG and IgM levels. Baseline was defined as the last available value prior to the first dose of study intervention. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Median | Inter-Quartile Range | gram/liter | Baseline (Day 1) to EOS (up to approximately 48 months) |
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From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months. Deaths were collected from baseline (Day 1) up to end of follow-up, approximately 48 months.
Analysis was performed on the safety population. This was an event-driven (6-month CDW) trial with a variable treatment duration (EOS duration: up to approximately 48 months).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally QD along with a placebo matched to tolebrutinib orally QD up to approximately 47 months. | 0 | 488 | 40 | 488 | 321 | 488 |
| EG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 48 months. | 0 | 486 | 42 | 486 | 296 | 486 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Chronic Sinusitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Chronic Tonsillitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Enteritis Infectious | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Respiratory Tract Chlamydial Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Salpingo-Oophoritis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Systemic Viral Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Adenocarcinoma Of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Benign Bone Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Benign Ovarian Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Breast Cancer Stage Ii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Invasive Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Soft Tissue Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Thinking Abnormal | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Central Nervous System Lesion | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Multiple Sclerosis Relapse | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Optic Neuritis | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Status Epilepticus | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Visual Field Defect | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Varicose Vein | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Epulis | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Gastrointestinal Erosion | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Drug-Induced Liver Injury | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDra 27.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
| |
| Intermenstrual Bleeding | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
| |
| Uterine Haemorrhage | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Burns Second Degree | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Hyphaema | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 27.0 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2024 | Jun 3, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C527525 | teriflunomide |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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A hierarchical testing procedure was used to control the overall type I error. |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| OG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 48 months. |
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| OG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 48 months. |
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