A Phase 2 interventional study of SAR441344 IV and placebo IV in Multiple Sclerosis, sponsored by Sanofi. Active, not recruiting at 37 sites in 10 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 129 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
SAR441344 IV
Drug: SAR441344 IV · Drug: MRI contrast-enhancing preparations
Placebo IV
Drug: placebo IV · Drug: MRI contrast-enhancing preparations
SAR441344 SC
Drug: SAR441344 SC · Drug: MRI contrast-enhancing preparations
Placebo SC
Drug: placebo SC · Drug: MRI contrast-enhancing preparations
Pharmaceutical form: Solution Route of administration: IV infusion
Pharmaceutical form: Solution Route of administration: IV infusion
Pharmaceutical form: Solution Route of administration: SC injection
Pharmaceutical form: Solution Route of administration: SC injection
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem
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.
Time frame: Week 8 and Week 12
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.
Time frame: Week 8 and Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
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.
| Milestone | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|---|
| Started | 14 | 12 | 51 | 52 |
| Completed | 14 | 12 | 49 | 50 |
| Not completed | 0 | 0 | 2 | 2 |
| Withdrew: Adverse event: related to coronavirus disease 2019 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
| Withdrew: Emergency situation due to war in ukraine | 0 | 0 | 0 | 2 |
| Milestone | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|---|
| Started | 0 | 0 | 63 | 62 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 63 | 62 |
| Withdrew: Ongoing at the time of pcd | 0 | 0 | 63 | 62 |
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.
| number of new GdE T1 lesions per month | Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|
| 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) | 1.4 (0.62 to 2.98) | 0.3 (0.13 to 0.59) | 0.2 (0.06 to 0.39) |
Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8.
| number of new or enlarging T2 lesions | Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|
| Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8 | 3.8 ± 6.2 | 0.6 ± 1.8 | 0.3 ± 0.7 |
Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12.
| number of GdE T1 lesions | Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|
| Mean Total Number of GdE T1 Lesions at Week 12 | 3.7 ± 7.4 | 0.5 ± 1.5 | 0.2 ± 0.5 |
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.
| Participants | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|---|
| TEAEs | 5 | 3 | 23 | 15 |
| TESAEs | 0 | 0 | 0 | 0 |
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.
| Participants | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|---|
| Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344 | 0 | 0 | 3 | 0 |
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.
| microgram per milliliter (mcg/mL) | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|
| After first dose | 196 ± 34.4 | 623 ± 125 |
| After last dose | 101 ± 20.9 | 580 ± 116 |
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.
| hour | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|
| After first dose | 1.5 (1 to 1.5) | 1.5 (1 to 2) |
| After last dose | 97.2 (79 to 123) | 1.38 (0.92 to 1.77) |
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.
| mcg*hour/mL | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|
| After first dose | 32800 ± 3560 | 157000 ± 23900 |
| After last dose | 31900 ± 7580 | 190000 ± 39400 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SC Placebo | 0/14 (0%) | 0/14 (0%) | 5/14 (35.7%) |
| IV Placebo | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| SC SAR441344 300 mg | 0/51 (0%) | 0/51 (0%) | 9/51 (17.6%) |
| IV SAR441344 1200 mg | 0/52 (0%) | 0/52 (0%) | 6/52 (11.5%) |
| Event | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg |
|---|---|---|---|---|
| Covid-19Infections and infestations | 0/14 | 0/12 | 5/51 | 0/52 |
| LeukopeniaBlood and lymphatic system disorders | 0/14 | 1/12 | 0/51 | 1/52 |
| AlopeciaSkin and subcutaneous tissue disorders | 0/14 | 1/12 | 0/51 | 0/52 |
| ErythemaSkin and subcutaneous tissue disorders | 0/14 | 1/12 | 0/51 | 0/52 |
| PruritusSkin and subcutaneous tissue disorders | 0/14 | 1/12 | 0/51 | 0/52 |
| Injection Site PainGeneral disorders | 0/14 | 1/12 | 1/51 | 1/52 |
| Injury Associated With DeviceGeneral disorders | 0/14 | 1/12 | 0/51 | 0/52 |
| Non-Cardiac Chest PainGeneral disorders | 0/14 | 1/12 | 0/51 | 0/52 |
| PyrexiaGeneral disorders | 0/14 | 1/12 | 0/51 | 0/52 |
| NasopharyngitisInfections and infestations | 1/14 | 0/12 | 2/51 | 2/52 |
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.
| Age, Continuous(years) | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg | Total |
|---|---|---|---|---|---|
| Mean | 31.6 ± 10.8 | 32.3 ± 7.7 | 38.2 ± 8.9 | 37.3 ± 9.3 | 36.6 ± 9.4 |
| Sex: Female, Male(Participants) | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg | Total |
|---|---|---|---|---|---|
| Female | 10 | 7 | 31 | 37 | 85 |
| Male | 4 | 5 | 20 | 15 | 44 |
| Race/Ethnicity, Customized(Participants) | SC Placebo | IV Placebo | SC SAR441344 300 mg | IV SAR441344 1200 mg | Total |
|---|---|---|---|---|---|
| Black or African American | 0 | 0 | 1 | 0 | 1 |
| White | 14 | 12 | 50 | 52 | 128 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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