NCT07325292 · Sanofi
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
(Frexcite)
What this study is about
This is a randomly assigned, where both patients and doctors know the treatment given, parallel, Phase 3 study with 2-treatment group$1 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.
- The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
- The participant must have at least 1 of the following prior to screening:
- 1 documented relapse within the previous year OR
- 2 documented relapses within the previous 2 years, OR
- 1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS)
- Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
- The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.
- The participant must have documented evidence of disability progression observed during the 12 months before screening.
- The participant must have an absence of clinical relapses for at least 24 months.
- The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit). Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply: \- Contraceptive 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 participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
- The participant has a history of infection or may be at risk for infection:
- Fever within 28 days of the Screening Visit
- Presence of psychiatric disturbance or substance abuse
- History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
- Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.
- A history or presence of disease that can mimic MS symptoms.
- The participant has a contraindication for MRI. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where
- Cullman, Alabama
- Homewood, Alabama
- Phoenix, Arizona
- Scottsdale, Arizona
- West Hollywood, California
- Fort Collins, Colorado
- Altamonte Springs, Florida
- Naples, Florida
- Ormond Beach, Florida
- West Palm Beach, Florida
- Smyrna, Georgia
- Northbrook, Illinois
And 8 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations