Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
NCT07325292 · View on ClinicalTrials.gov ↗
Study Summary
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 or 11 for participants receiving frexalimab SC or IV, respectively, 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.
Conditions Studied
Interventions
- DRUG Frexalimab
- DRUG MRI contrast-enhancing preparations
Study Locations (10)
Florida
- Neurology of Central Florida- Site Number : 8400147 — Altamonte Springs
- Aqualane Clinical Research- Site Number : 8400026 — Naples
- Neurology Associates of Ormond Beach- Site Number : 8400086 — Ormond Beach
Alabama
- North Central Neurology Associates- Site Number : 8401100 — Cullman
- Alabama Neurology Associates- Site Number : 8400115 — Homewood
North Carolina
- Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 — Charlotte
- Raleigh Neurology Associates- Site Number : 8400014 — Raleigh
Arizona
- Perseverance Research Center- Site Number : 8400138 — Scottsdale
California
- Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood
Tennessee
- Hope Neurology- Site Number : 8400019 — Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2026-01-14 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07325292
The ClinicalTrials.gov registry entry for NCT07325292 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Frexalimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07325292 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Florida, Alabama, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07325292 about?
NCT07325292 is a clinical study titled "Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis". 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 ...
What is the current status of trial NCT07325292?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2026-01-14. Estimated completion is 2028-11-30.
What conditions does trial NCT07325292 study?
This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07325292?
The interventions under investigation include: Frexalimab (DRUG), MRI contrast-enhancing preparations (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07325292?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07325292 being conducted?
This trial has 10 study locations across Alabama, Arizona, California, Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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