Trial · NCT06141473
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
NCT06141473, Phase 3, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis. Trials, record NCT06141473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06141473
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
- NCT number
- NCT06141473
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,655 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Multiple Sclerosis
- Interventions
- Frexalimab, Teriflunomide, Placebo infusion, Placebo tablet, MRI contrast-enhancing agents, Cholestyramine, Activated charcoal
- First posted
- 2023-11-21
- Last updated
- 2026-07-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses | Until Week 156 | ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, ≥4), and geographical region (US, non-US). |
| Secondary | Time to onset of composite confirmed disability worsening (cCDW) | Until Week 156 | confirmed over 6 months as assessed by the composite of: * increase from the baseline expanded disability status scale (EDSS) score of ≥1.5 points when the baseline is 0, or ≥1.0 point when the baseline is 0.5 to 5.0, or ≥0.5 point when the baseline is ≥5.5, OR * increase of ≥20% from the baseline time in the 9-hole peg test (9HPT), OR * increase of ≥20% from the baseline time in the Timed 25-foot walk (T25FW) test |
| Secondary | Time to onset of cCDW, confirmed over 3 months | Until Week 156 | |
| Secondary | Time to onset of individual components of the composite, confirmed over 3-months or 6-months | Until Week 156 | |
| Secondary | Time to onset of confirmed disability improvement (CDI) | Until Week 156 | defined as decrease from baseline EDSS score of ≥1.0 or ≥ 0.5 points when the baseline is ≥2 to ≤5.5 or \>5.5 points, respectively, confirmed over 6 months. No improvement possible for 0 to 1.5 points |
| Secondary | Progression independent of relapse activity defined as the time to onset of 6-month cCDW | Until Week 156 | defined by either no prior relapse or an onset more than 90 days after the start date of the last adjudicated relapse |
| Secondary | Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI | Until Week 156 | defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the EOS visit |
| Secondary | Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI | Until Week 156 | defined as the sum of the individual number of new Gd enhancing T1-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit divided by the number of scans |
| Secondary | Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6 | From Week 24 to Week 156 | |
| Secondary | Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT) | From baseline to Week 156 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39899371 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06141473
GET https://conductscience.org/api/trials/v1/NCT06141473/registered