Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-3962 | Registry Identifier | ICTRP | |
| 2024-513527-17-00 | Registry Identifier | CTIS | |
| 2020-004785-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions
Secondary Objective:
The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous (IV) SAR441344 | Experimental | SAR441344 IV |
|
| IV Placebo | Placebo Comparator | Placebo IV |
|
| Subcutaneous (SC) SAR441344 | Experimental | SAR441344 SC |
|
| SC Placebo | Placebo Comparator | Placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR441344 IV | Drug | Pharmaceutical form: Solution Route of administration: IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI) | Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans. | Week 8 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8 | Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8. | Week 8 and Week 12 |
| Mean Total Number of GdE T1 Lesions at Week 12 |
Not provided
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurology and Spine- Site Number : 8400007 | Phoenix | Arizona | 85032 | United States | ||
| University of South Florida Site Number : 8400001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38354138 | Derived | Vermersch P, Granziera C, Mao-Draayer Y, Cutter G, Kalbus O, Staikov I, Dufek M, Saubadu S, Bejuit R, Truffinet P, Djukic B, Wallstroem E, Giovannoni G; Frexalimab Phase 2 Trial Group. Inhibition of CD40L with Frexalimab in Multiple Sclerosis. N Engl J Med. 2024 Feb 15;390(7):589-600. doi: 10.1056/NEJMoa2309439. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
A total of 129 participants were randomized in a 4:4:1:1 ratio to receive either intravenous (IV) SAR441344 or subcutaneous (SC) SAR441344 or IV placebo or SC placebo in Part A (double-blind [DB] period). After completing Part A, all participants entered Part B (open-label extension [OLE] period) where participants in the IV and SC placebo arms switched to corresponding IV and SC SAR441344 arms and participants from SAR441344 arms continued their previous IV or SC treatment after Week 12 visit.
The study was conducted at 38 centers in 10 countries. A total of 176 participants were screened from 07 June 2021 to 08 June 2022, of which 47 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria. Primary results are presented up to primary completion date (PCD) of 21 September 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SC Placebo | Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 milligram (mg) every 2 weeks (q2w) and then switched to high SC SAR441344 dose of 1800 mg every 4 weeks (q4w) in Part B (OLE period). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A: DB Period (Up to Week 12) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2024 | Sep 11, 2025 |
Not provided
Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Not provided
Not provided
Not provided
| placebo IV | Drug | Pharmaceutical form: Solution Route of administration: IV infusion |
|
| SAR441344 SC | Drug | Pharmaceutical form: Solution Route of administration: SC injection |
|
| placebo SC | Drug | Pharmaceutical form: Solution Route of administration: SC injection |
|
| MRI contrast-enhancing preparations | Drug | gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem |
|
Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12. |
| Baseline (Day 1) and Week 12 |
| Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An 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 or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | From first dose of study drug (Day 1) up to 12 weeks (DB TE period) |
| Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344 | Blood samples were collected at specified timepoints to assess the presence of ADAs against SAR441344. Treatment-emergent ADA was defined as at least 1 treatment-induced/boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA are presented. | From first dose of study drug (Day 1) up to 12 weeks (DB TE period) |
| Maximum Plasma Concentration (Cmax) of SAR441344 | Blood samples were collected at the specified timepoints for the assessment of Cmax. Cmax was assessed by a Bayesian approach using the population pharmacokinetic (PK) model. | After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose) |
| Time to Maximum Plasma Concentration (Tmax) of SAR441344 | Blood samples were collected at the specified timepoints for the assessment of tmax. tmax was assessed by a Bayesian approach using the population PK model. | After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose) |
| Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344 | Blood samples were collected at the specified timepoints for the assessment of AUC0-tau. AUC0-tau was assessed by a Bayesian approach using the population PK model. | After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose) |
| Tampa |
| Florida |
| 33612 |
| United States |
| The Neurological Institute Site Number : 8400004 | Charlotte | North Carolina | 28204 | United States |
| Medical College of Wisconsin- Site Number : 8400006 | Milwaukee | Wisconsin | 53226 | United States |
| Investigational Site Number : 1000002 | Pleven | 5809 | Bulgaria |
| Investigational Site Number : 1000003 | Sofia | 1113 | Bulgaria |
| Investigational Site Number : 1000001 | Sofia | 1407 | Bulgaria |
| Investigational Site Number : 1240001 | Gatineau | Quebec | J8Y 1W2 | Canada |
| Investigational Site Number : 2030003 | Brno | 65691 | Czechia |
| Investigational Site Number : 2030002 | Hradec Králové | 50005 | Czechia |
| Investigational Site Number : 2030001 | Jihlava | 58633 | Czechia |
| Investigational Site Number : 2030005 | Ostrava - Poruba | 70852 | Czechia |
| Investigational Site Number : 2030004 | Teplice | 415 29 | Czechia |
| Investigational Site Number : 2500006 | Calais | 62107 | France |
| Investigational Site Number : 2760012 | Leipzig | 04103 | Germany |
| Investigational Site Number : 2760004 | Münster | 48149 | Germany |
| Investigational Site Number : 6430002 | Kazan' | 420032 | Russia |
| Investigational Site Number : 6430007 | Moscow | 117556 | Russia |
| Investigational Site Number : 6430006 | Moscow | 117997 | Russia |
| Investigational Site Number : 6430001 | Moscow | 127015 | Russia |
| Investigational Site Number : 6430003 | Saint Petersburg | 194044 | Russia |
| Investigational Site Number : 6430005 | Saint Petersburg | 197022 | Russia |
| Investigational Site Number : 6430004 | Saint Petersburg | 197110 | Russia |
| Investigational Site Number : 6430008 | Tyumen | 625000 | Russia |
| Investigational Site Number : 7240004 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number : 7240002 | Vigo | 36312 | Spain |
| Investigational Site Number : 7920004 | Eskişehir | 26040 | Turkey (Türkiye) |
| Investigational Site Number : 7920003 | Istanbul | 34265 | Turkey (Türkiye) |
| Investigational Site Number : 7920001 | İzmit | 41380 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number : 8040010 | Dnipro | 49005 | Ukraine |
| Investigational Site Number : 8040006 | Dnipro | 49089 | Ukraine |
| Investigational Site Number : 8040008 | Ivano-Frankivsk | 76493 | Ukraine |
| Investigational Site Number : 8040002 | Kyiv | 01135 | Ukraine |
| Investigational Site Number : 8040004 | Lviv | 79013 | Ukraine |
| Investigational Site Number : 8040003 | Odesa | 65025 | Ukraine |
| Investigational Site Number : 8040005 | Vinnytsia | 21001 | Ukraine |
| FG001 | IV Placebo | Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period). |
| FG002 | SC SAR441344 300 mg | Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). |
| FG003 | IV SAR441344 1200 mg | Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B: OLE Period (Up to Week 296) |
|
|
The randomized population included all participants from screened population who were allocated to a randomized study drug by interactive response technology regardless of whether the study drug was received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SC Placebo | Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 mg q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). |
| BG001 | IV Placebo | Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period). |
| BG002 | SC SAR441344 300 mg | Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). |
| BG003 | IV SAR441344 1200 mg | Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI) | Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans. | The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the statistical analysis plan (SAP), data for placebo arm is presented by pooling SC and IV placebo arms. | Posted | Least Squares Mean | 95% Confidence Interval | number of new GdE T1 lesions per month | Week 8 and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8 | Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8. | The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the SAP, data for placebo arm is presented by pooling SC and IV placebo arms. | Posted | Mean | Standard Deviation | number of new or enlarging T2 lesions | Week 8 and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Total Number of GdE T1 Lesions at Week 12 | Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12. | The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the SAP, data for placebo arm is presented by pooling SC and IV placebo arms. | Posted | Mean | Standard Deviation | number of GdE T1 lesions | Baseline (Day 1) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An 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 or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period. | The safety population included all randomized participants who took at least 1 dose (regardless of the amount) of study drug. | Posted | Count of Participants | Participants | From first dose of study drug (Day 1) up to 12 weeks (DB TE period) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344 | Blood samples were collected at specified timepoints to assess the presence of ADAs against SAR441344. Treatment-emergent ADA was defined as at least 1 treatment-induced/boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA are presented. | The ADA population included all participants from the safety population treated with SAR441344 in Part A with at least 1 post-baseline ADA result (positive, negative or inconclusive). | Posted | Count of Participants | Participants | From first dose of study drug (Day 1) up to 12 weeks (DB TE period) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of SAR441344 | Blood samples were collected at the specified timepoints for the assessment of Cmax. Cmax was assessed by a Bayesian approach using the population pharmacokinetic (PK) model. | The PK population included all randomized and treated participants (safety population) with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration (Tmax) of SAR441344 | Blood samples were collected at the specified timepoints for the assessment of tmax. tmax was assessed by a Bayesian approach using the population PK model. | The PK population included all randomized and treated participants (safety population) with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. | Posted | Median | Full Range | hour | After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344 | Blood samples were collected at the specified timepoints for the assessment of AUC0-tau. AUC0-tau was assessed by a Bayesian approach using the population PK model. | The PK population included all randomized and treated participants (safety population) with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | mcg*hour/mL | After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose) |
|
AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks
Analysis was performed on safety population.
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 | SC Placebo | Participants received placebo matched to SAR441344 IV infusion loading dose on Day 1 followed by placebo matched to SAR441344 SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, all participants from this arm switched to active SC SAR441344 300 mg q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). | 0 | 14 | 0 | 14 | 5 | 14 |
| EG001 | IV Placebo | Participants received placebo matched to SAR441344 loading dose on Day 1 followed by placebo matched to SAR441344 IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, all participants from this arm switched to active IV SAR441344 1200 mg infusion q4w in Part B (OLE period). | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | SC SAR441344 300 mg | Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). | 0 | 51 | 0 | 51 | 9 | 51 |
| EG003 | IV SAR441344 1200 mg | Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period). | 0 | 52 | 0 | 52 | 6 | 52 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Defaecation Urgency | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Ingrowing Nail | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDra 25.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Injection Site Extravasation | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Injury Associated With Device | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDra 25.0 | 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 ext 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2022 | Sep 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| White |
|
Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8. |
| Rate ratio |
| 0.11 |
| 2-Sided |
| 95 |
| 0.03 |
| 0.38 |
| Superiority |
|
|
|
|
| OG002 | SC SAR441344 300 mg | Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). |
| OG003 | IV SAR441344 1200 mg | Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period). |
|
|
| OG002 | SC SAR441344 300 mg | Participants received SAR441344 600 mg IV infusion loading dose on Day 1 followed by SAR441344 300 mg SC injection on Weeks 2, 4, 6, 8 and 10 in Part A (DB period). At Week 12, participants continued to receive SAR441344 300 mg SC injection q2w and then switched to high SC SAR441344 dose of 1800 mg q4w in Part B (OLE period). |
| OG003 | IV SAR441344 1200 mg | Participants received SAR441344 1800 mg loading dose on Day 1 followed by SAR441344 1200 mg IV infusion at Weeks 4 and 8 in Part A (DB period). At Week 12, participants continued to receive SAR441344 1200 mg IV infusion q4w in Part B (OLE period). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|