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Compares treatment options for Multiple Sclerosis
Official title Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
ClinicalTrials.gov ID: NCT07325292
What this study is testing
What is Frexalimab?
Frexalimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple sclerosis.
Also referred to as SAR441344.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the 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:
You likely can't join if
- 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...
- Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.
See the full eligibility criteria
- The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Homewood, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- West Hollywood, California, United States
- Fort Collins, Colorado, United States
- Altamonte Springs, Florida, United States
- Naples, Florida, United States
- Ormond Beach, Florida, United States
- West Palm Beach, Florida, United States
- Smyrna, Georgia, United States
- Northbrook, Illinois, United States
- Farmington Hills, Michigan, United States
- Teaneck, New Jersey, United States
- Charlotte, North Carolina, United States
- Raleigh, North Carolina, United States
- Columbus, Ohio, United States
- Knoxville, Tennessee, United States
- El Paso, Texas, United States
- Plano, Texas, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Homewood, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; West Hollywood, California, United States; Fort Collins, Colorado, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.