A Phase 3 interventional study of Frexalimab and Frexalimab in Multiple Sclerosis, sponsored by Sanofi. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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Among 44 studies in Multiple Sclerosis by Sanofi — 3 open to participants now, 6 under way, 4 of them phase 3. Multiple Sclerosis · Sanofi.
Among the 44 studies in Multiple Sclerosis by Sanofi, this one has the largest planned enrollment of the 41 interventional ones that give a count, is the only one that started in 2027, is one of 18 in phase 3, and was the 44th registered.
3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.
Browse Multiple Sclerosis studies →3 of the 44 studies in Multiple Sclerosis by Sanofi are open now, in 8 countries. Recruiting first, the newest first:
Sanofi · Sites in United Arab Emirates
Ages 18+
Sanofi · Sites in United States, Belgium, Brazil and 4 more countries
Ages 18–60
By country, each count listing its studies:
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2,500 is above the median of 50 across 2,203 interventional studies indexed under Multiple Sclerosis.
Median enrollment 166 across the 41 interventional studies, 220 across the 3 observational. Of the 38 that completed or were terminated, 23 (61%) have results posted.
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Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
2 of the studies in Multiple Sclerosis by Sanofi that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT07325292Phase 3SanofiNon-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | 2027-07-15 |
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Among the 44 studies in Multiple Sclerosis by Sanofi, from their registry updates:
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Study LTS18002 is a global, multicenter, open-label (OL), Phase 3, long-term safety and efficacy extension study.
The purpose of this study is to provide continued access to frexalimab for participants with MS, and to evaluate the long-term safety and efficacy profile of frexalimab. This study will monitor delayed AEs, assess the durability of safety findings and characterize any emerging safety signals that may develop over an extended follow up period.
Study details include:
The number of visits over the 2-year duration will be dependent on subgroup assignment which is based on parent study from which the participant has entered the LTS18002 :
ACT16877, EFC17504, EFC18098, and ASY22814 participants
Will have on-site visits every 12 weeks (9 visits)
Additionally, there will be 16 on-site visits for OL frexalimab administration (Week 4, 8, 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92) for all participants EXCEPT those entering from EFC18098 (frexalimab open label administration is conducted at home via SC large volume (OBDS VT) device)
There will be 3 follow up visits beginning 4 weeks after the last administration of OL frexalimab
Home administration is allowed for participants from ACT16877, based on Investigator judgement, participant/caregiver training and local availability. Home nurse services are mandatory for at-home administration.
Home nurse services for at home administration may be considered for EFC17504 participants after Week 24 administration of OL frexalimab, based on availability. Participants that have initiated OL frexalimab via home administration during the parent study may continue to receive it in this manner.
EFC17919A/B participants
Will have on site visits every 12 weeks (9 visits)
Will have a total of 16 visits for OL frexalimab administration (Week 4, 8, 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92)
Additionally, there will be up to 3 visits for administration of DB treatment (until results become available and randomization assignment availability).
NOTE: all on-site visits including monthly IMP administrations will include safety labs (biochemistry, hematology liver chemistry, and immunoglobulins) and physical exams.
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.
- Participants with relapsing multiple sclerosis(RMS) or non-relapsing secondary progressive multiple sclerosis(nrSPMS) who completed, on IMP, the Phase 2 ACT16877 study, or one of the four Phase 3 frexalimab studies in MS indication (EFC17919A and EFC17919B, EFC17504, EFC18098), or planned Phase 2 biomarker ASY22814.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant'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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered frexalimab subcutaneous
Drug: Frexalimab · Drug: MRI contrast-enhancing agents
Participants will be administered frexalimab intravenously
Drug: Frexalimab · Drug: MRI contrast-enhancing agents
For EFC17919A/B parent study participants: at Opt-in visit participants will continue to be administered f rexalimab through unblinding visit. Participants will receive placebo tablet once daily until the unblinding visit.
Drug: Frexalimab · Drug: Teriflunomide Placebo · Drug: MRI contrast-enhancing agents · Drug: Cholestyramine · Drug: charcoal
For EFC17919A/B parent study participants: at Opt-in visit participants will continue to receive teriflunomide tablet. The placebo will be administered to participants at the same infusion rate and duration as for frexalimab from the opt-in visit until availability of results and unblinding.
Drug: Frexalimab Placebo · Drug: Teriflunomide · Drug: MRI contrast-enhancing agents · Drug: Cholestyramine · Drug: charcoal
Pharmaceutical form:Solution for injection-Route of administration:SC
Also known as: SAR441344
Pharmaceutical form:Solution for infusion-Route of administration:IV
Also known as: SAR441344
Pharmaceutical form:Solution for infusion-Route of administration:IV
Pharmaceutical form:Tablet-Route of administration:Oral
Pharmaceutical form:Tablet-Route of administration:Oral
Route of administration:IV
Route of administration:oral
Route of administration:oral
Number of participants with Adverse Events(AEs)
Number of participants with Adverse Events(AEs), serious adverse event(SAEs), AEs leading to permanent study intervention discontinuation, adverse event of special interest(AESIs), local tolerability, clinically significant abnormalities in laboratory tests, Columbia-Suicide Severity Rating Scale(C-SSRS)
Time frame: up to to approximately 2.5 years since last participant in
Participants from EFC17919A, EFC17919B, and EFC17504 studies only: time to onset of 6-month composite confirmed disability worsening(cCDW) for RMS or composite confirmed disability progression(cCDP) for nrSPMS
Time frame: up to to approximately 2.5 years since last participant in
Time to onset of individual components of the composite, confirmed over 3 months or 6 months EDSS for all prior study participants 9-HPT, T25FW test (participants rolling over from EFC17504, EFC17919A, and EFC17919B)
Time frame: up to to approximately 2.5 years since last participant in
Progression independent of relapse activity defined as the time to onset of 6-month cCDW
Progression independent of relapse activity defined as the time to onset of 6-month cCDW, defined by either no prior relapse or an onset more than 90 days after the start date of the last Investigator reported relapse (participants rolling over from EFC17919A and EFC17919B)
Time frame: up to to approximately 2.5 years since last participant in
Number of new and/or enlarging T2-hyperintense lesions per year as detected by MRI
Time frame: up to to approximately 2.5 years since last participant in
Total number of new GdE T1 lesions per year as detected by MRI
Time frame: up to to approximately 2.5 years since last participant in
Change from baseline at scheduled visits in total volume of T2-hyperintense lesions as detected by brain MRI
Time frame: up to to approximately 2.5 years since last participant in
ARR assessed by confirmed protocol defined relapses
Time frame: up to to approximately 2.5 years since last participant in
antidrug antibodys(ADAs) incidence
Time frame: up to to approximately 2.5 years since last participant in
Change from baseline in serum immunoglobulin(Ig) levels
Time frame: up to to approximately 2.5 years since last participant in
No study locations are listed for this record.
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
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for May 2031, 51 months later.
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 51 months is above 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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Frexalimab · Cholestyramine Resin · Charcoal