A Phase 3 interventional study of Frexalimab and Frexalimab in Multiple Sclerosis, sponsored by Sanofi. Recruiting at 68 sites in 7 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.
The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.
The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group:
Group A (RMS)
The participant must have at least 1 of the following prior to screening:
Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply:
- use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement)
Drug: Frexalimab · Drug: MRI contrast-enhancing preparations
Frexalimab IV
Drug: Frexalimab · Drug: MRI contrast-enhancing preparations
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Also known as: SAR441344
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Also known as: SAR441344
Route of administration:IV injection
Area under the curve over the interval W20 to W24(part A)
AUCW20-W24
Time frame: Until Week 24
Trough concentration at steady state(part A)
Ctrough,SS
Time frame: Until Week 24
Frexalimab plasma concentrations over time (part A for IV Arm Part A, B, C for SC arm)
Time frame: Until Week 24 for IV arm, Until EOS for SC arm ( until Week 96)
Pharmacokinetic parameters: Cmax(part A)
Time frame: Until Week 24
Pharmacokinetic parameters: Tmax(part A)
Time frame: Until Week 24
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and potentially clinically significant abnormality(PCSA) in laboratory tests, and vital signs during the study period
Time frame: Until Week 96
Incidence of ADAs over time. (part A, B and C)
Time frame: through study completion, an average of 48 weeks
Total number of Gd-enhancing T1 lesions at W12 and W24(part A)
Time frame: At Week 12 and Week 24
Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months
Time frame: Until week 96
Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study
Time frame: Until week 96
Percentage of participants that prefer SC administration over IV administration assessed by Items 13 and 14 of the PESQ at Week 48 completed by participants that switched from IV to SC in Part B.
Time frame: From week 24 to week 48
Total number of GdE T1 lesions at W48(part B)
Time frame: At week 48
Total number of GdE T1 lesions at W96 and yearly thereafter.(part C)
Time frame: At week 96 and yearly thereafter
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
Started Jan 2026 (actual). Primary completion is estimated for Jul 2027, 18 months after the start.
Of 71 industry-sponsored phase 3 interventional studies under Multiple Sclerosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 54. This study's planned 18 months is below that.
Counting every sponsor, half of 96 studies reached it within 42 months; a quarter within 26 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Frexalimab