Study on the Effectiveness and Safety of Frexalimab and Teriflunomide in Adults with Relapsing Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment for multiple sclerosis, specifically for its relapsing forms. Multiple sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. The study will compare a new medication called frexalimab (also known by its code name SAR441344) with an existing treatment called teriflunomide, which is available as AUBAGIO 14 mg film-coated tablets. Frexalimab is administered as a solution for injection, while teriflunomide is taken orally in tablet form.

The purpose of the study is to assess how well frexalimab works compared to teriflunomide in reducing the frequency of relapses in people with relapsing forms of multiple sclerosis. Participants in the study will receive either frexalimab, teriflunomide, or a placebo, which is a substance with no active medication. The study will last for a period of up to 160 weeks, during which participants will be monitored for any changes in their condition, including the number of relapses they experience and any side effects they may encounter.

Throughout the study, various assessments will be conducted, such as MRI scans to detect changes in the brain, and tests to evaluate cognitive function and overall impact on daily life. The study will also monitor for any adverse events or reactions to the medications. The goal is to gather comprehensive data on the safety and effectiveness of frexalimab as a potential new treatment option for individuals with relapsing forms of multiple sclerosis.

1 initial visit

Upon joining the study, you will have an initial visit where your eligibility will be confirmed. This includes a review of your medical history and a physical examination.

You will be asked to provide information about any previous relapses or MRI scans showing specific brain changes related to multiple sclerosis.

2 randomization

After confirming eligibility, you will be randomly assigned to one of two groups. One group will receive the medication frexalimab, and the other will receive teriflunomide.

This process is random to ensure the study’s fairness and accuracy.

3 medication administration

If you are in the frexalimab group, you will receive this medication through an intravenous infusion, which means it will be given directly into your vein.

If you are in the teriflunomide group, you will take a 14 mg film-coated tablet orally once a day.

4 regular follow-up visits

You will have regular follow-up visits to monitor your health and the effects of the medication. These visits will include physical exams and possibly MRI scans to check for changes in your condition.

You will be asked about any side effects or changes in your symptoms.

5 end of study procedures

At the end of the study, you will have a final visit to assess your overall health and the impact of the treatment.

This may include a final physical exam, MRI scans, and discussions about your experience during the trial.

Who Can Join the Study?

  • The participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria. This means the participant has a specific type of multiple sclerosis that comes and goes.
  • The participant has an EDSS score of 5.5 or less at the first visit (Screening Visit). The EDSS score is a way to measure how much the disease affects the participant’s ability to move and perform daily activities.
  • The participant must have at least one of the following before the screening:
    • At least one documented relapse (a return of symptoms) within the previous year.
    • At least two documented relapses within the previous two years.
    • At least one documented Gd enhancing lesion on an MRI scan within the previous year. A Gd enhancing lesion is a specific type of change seen in the brain or spinal cord on an MRI scan, which indicates active inflammation.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. This means participants must follow local rules about birth control while in the study.
  • The study is open to both male and female participants.
  • The study includes participants who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of multiple sclerosis cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent infection or illness that could affect the study cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have allergies to the study medication or similar drugs cannot participate.
  • Patients who have received certain treatments or medications recently that could interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Centre Hospitalier De Colmar Colmar France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Krajska zdravotni a.s. Teplice Czechia
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Avis Medika OOD Pleven Bulgaria
Resmedica Sp. z o.o. Kielce Poland
Ma-Lek Clinical Sp. z o.o. Katowice Poland
KBC Zagreb Zagreb Croatia
General University Hospital Of Larissa Larissa Greece
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Clinexpert Kft. Budapest Hungary
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Brno Brno Czechia
Philipps-Universitaet Marburg Marburg Germany
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Pratia S.A. Skorzewo Poland
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
St. Luke’s Hospital S.A. Thessaloniki Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Rigshospitalet Copenhagen Denmark
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Spitalul Clinic Cai Ferate Constanta Constanta Romania
Universita’ Degli Studi Di Ferrara Ferrara Italy
University Hospital Ostrava Ostrava Czechia
Neuro Centrum Science GmbH Erbach Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Ajhhnpe Onxbtwcggco Uqltfisgbccbg Phrvt Parma Italy
Ubliqomyecgyfbhcdltfz Eybsx Agi Essen Germany
Cjroxccz Hfrhbjpwkbnq Ujzfzvxaerucf Dq Vrul Vigo Spain
Mnrsstfarrol Vmptrmmnpdfpazygli Sgq Jezzdgsgcxwgafldal Pndevlt Gsqk Potsdam Germany
Cvedwq Hfivomzxufq Do Jhwi Ejrn Toqlvr Calais France
Uojtbnjlw Saejjmkhypdkpol Cxjlnln Lgxkwtqy Cgvbsb Secrn I Npxexz &pmwe Utjvjyfsx Sygwhkkztoexnsi Cmsront Mwugkadu &iwhp Urealzkdgiy Cibbopt Cpfxqsqle Pxzqqclfyry Rhulotsycxtkkvxu I Mwcciawn Egtcmzwyjpp Mbpnmouywee Kuqhtym Stxkknunktddzdi Shw z odzc Cracow Poland
Nergplgcxyjs Bwwdmbunl Bielefeld Germany
Uodazzjdzjm nayqytrqa &hfgulx Nkvucvpnw sicqkrb Mjpxwbfw ad s Bratislava Slovakia
Fajtezgn nrsmdhcnd Mpltm a Hgnzzcg Prague Czechia
Ujxhnqfocptktdmszjthl Mtxrntpy Ado Munster Germany
Hlpsowzv Uvdkmvvkktara Dytiglfx Donostia / San Sebastian Spain
Uzsxbiqywh Dkeor Scmks Dw Riie Ln Sfkotftv Rome Italy
Ciwbvy Hqcnrpknvs E Uxcpfobyizulf Dv Congbgp Edstiq Coimbra Portugal
Cpowwei Nfbhykqduc Kscibcxld Suyqjg Lodz Poland
Jpyudnzy Kfrhdk Ulbmqlypxw Linz Austria
Pkroldnjqwqmcuanye Mztqcpdampatq Vienna Austria
Sqrlrtidh Kfha Budapest Hungary
Scwuwxfnyrxspv Dml Bbucfbo Gdoc Böblingen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
09.09.2024
Bulgaria Bulgaria
Not recruiting
09.09.2024
Croatia Croatia
Not recruiting
09.09.2024
Czechia Czechia
Not recruiting
09.09.2024
Denmark Denmark
Not recruiting
09.09.2024
France France
Not recruiting
09.09.2024
Germany Germany
Not recruiting
09.09.2024
Greece Greece
Not recruiting
09.09.2024
Hungary Hungary
Not recruiting
09.09.2024
Italy Italy
Not recruiting
09.09.2024
Lithuania Lithuania
Not recruiting
09.09.2024
Poland Poland
Not recruiting
09.09.2024
Portugal Portugal
Not recruiting
09.09.2024
Romania Romania
Not recruiting
09.09.2024
Slovakia Slovakia
Not recruiting
09.09.2024
Spain Spain
Not recruiting
09.09.2024

Trial locations

Frexalimab is a medication being studied for its potential to help people with relapsing forms of multiple sclerosis (MS). It works by targeting specific parts of the immune system that are thought to be involved in the inflammation and damage to the nervous system seen in MS. The goal of using frexalimab is to reduce the number of relapses, which are periods when symptoms of MS get worse.

Teriflunomide is an existing medication used to treat relapsing forms of multiple sclerosis. It helps to reduce the frequency of relapses by limiting the activity of certain immune cells that can cause damage to the nervous system. Teriflunomide is taken as a daily pill and is designed to help manage the symptoms of MS and slow down the progression of the disease.

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system mistakenly attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. The disease can manifest in various forms, with relapsing-remitting multiple sclerosis being the most common, where symptoms flare up and then improve. Over time, multiple sclerosis can cause permanent damage or deterioration of the nerves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can lead to increased disability and impact on daily life activities.

Trial ID:
2024-514343-29-00
Protocol code:
EFC17919B
NCT ID:
NCT06141473
Trial Phase:
Therapeutic confirmatory (Phase III)

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