A Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis
NCT07930624, Phase 3, Not yet recruiting, Sanofi
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT07930624 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 2,500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis | ClinicalTrials.gov |
| Interventions | Frexalimab, Frexalimab, Frexalimab Placebo, Teriflunomide, Teriflunomide Placebo, MRI contrast-enhancing agents, Cholestyramine, charcoal | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of participants with Adverse Events(AEs) | up to to approximately 2.5 years since last participant in | 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) | ClinicalTrials.gov |
| Secondary | 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 | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | 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) | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | Progression independent of relapse activity defined as the time to onset of 6-month cCDW | 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, 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) | ClinicalTrials.gov |
| Secondary | Number of new and/or enlarging T2-hyperintense lesions per year as detected by MRI | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | Total number of new GdE T1 lesions per year as detected by MRI | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | Change from baseline at scheduled visits in total volume of T2-hyperintense lesions as detected by brain MRI | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | ARR assessed by confirmed protocol defined relapses | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | antidrug antibodys(ADAs) incidence | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov | |
| Secondary | Change from baseline in serum immunoglobulin(Ig) levels | up to to approximately 2.5 years since last participant in | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
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 | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.