Study on the Effectiveness and Safety of Remibrutinib Compared to Teriflunomide for Patients with Relapsing Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of two treatments for Multiple Sclerosis, a disease that affects the brain and spinal cord, leading to symptoms like fatigue, difficulty walking, and vision problems. The study compares the effectiveness and safety of a new medication called remibrutinib with an existing treatment known as teriflunomide. Participants will receive either remibrutinib or teriflunomide, and some may receive a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to determine if remibrutinib is better than teriflunomide in reducing the number of relapses, which are periods when symptoms of multiple sclerosis suddenly get worse. The study will begin with a period where participants are randomly assigned to receive either remibrutinib or teriflunomide. After this initial phase, all participants will have the opportunity to receive remibrutinib for an extended period. This approach helps researchers understand the long-term effects of remibrutinib on multiple sclerosis.

Throughout the study, participants will take their assigned medication by mouth, and their health will be monitored regularly. This includes checking for any new symptoms, changes in their condition, and any side effects from the medication. The study aims to provide valuable information about how well remibrutinib works compared to teriflunomide and to ensure the safety of participants while they are taking these medications.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the study medication or the comparison medication.

2 initial treatment phase

Participants receive either remibrutinib or teriflunomide. Remibrutinib is administered as a 100 mg film-coated tablet taken orally. Teriflunomide is given as a 14 mg capsule, also taken orally.

The purpose of this phase is to compare the effectiveness and safety of remibrutinib against teriflunomide in reducing the frequency of relapses in individuals with relapsing multiple sclerosis.

3 monitoring and assessments

Throughout the trial, participants undergo regular monitoring and assessments. These include evaluations of disability progression, the number of new or enlarging lesions on MRI scans, and other health indicators.

Participants’ blood samples are collected to measure the concentration of neurofilament light chain, a marker of nerve damage, and remibrutinib levels.

4 extended treatment phase

After the initial treatment phase, all participants receive open-label remibrutinib. This means that both the participants and the researchers know that remibrutinib is being administered.

The extended treatment phase allows for the long-term evaluation of remibrutinib’s safety and effectiveness.

5 completion and follow-up

The trial is expected to conclude by October 2030. Upon completion, participants may undergo final assessments to evaluate the overall impact of the treatment.

Follow-up procedures may be conducted to monitor participants’ health and gather additional data on the long-term effects of the treatment.

Who Can Join the Study?

  • Participants must provide a signed informed consent before any study-related assessments are done.
  • Participants can be male or female and must be between 18 and 55 years old at the time of screening.
  • Participants must have a diagnosis of RMS (Relapsing Multiple Sclerosis) according to the 2017 McDonald diagnostic criteria. This includes RRMS (Relapsing-Remitting Multiple Sclerosis) or active SPMS (Secondary Progressive Multiple Sclerosis).
  • Participants must have had at least one of the following:
    • 1 documented relapse in the past year,
    • 2 documented relapses in the past 2 years,
    • 1 active Gadolinium (Gd)-enhancing lesion in the past 12 months. A Gadolinium-enhancing lesion is a spot on an MRI scan that shows active inflammation in the brain.
  • Participants must have an EDSS score between 0 and 5.5 at screening and randomization. The EDSS score is a way to measure disability in people with Multiple Sclerosis.
  • Participants must be neurologically stable for at least 1 month before screening and randomization, meaning no MS relapses during this time.

Who Cannot Join the Study?

  • Patients who have a different condition than Multiple Sclerosis cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are considered part of a vulnerable population may not be eligible.
  • Patients who do not meet other specific criteria set by the study may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Hospital Universitario da A Coruna A Coruna Galicia Spain
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Kepler Universitaetsklinikum GmbH Linz Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
University Of Antwerp Edegem Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario De La Princesa Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Hospital Clinico Universitario De Valladolid Valladolid Spain
Medical Center Medconsult Pleven OOD Pleven Bulgaria
Hospital Universitario Virgen De La Victoria Malaga Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Pauls Stradins Clinical University Hospital Riga Latvia
KBC Zagreb Zagreb Croatia
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Med Polonia Sp. z o.o. Poznan Poland
Clinical Medical Center Osijek Osijek Croatia
Hospital Santa Caterina Ias Salt Spain
Centrum Neurologii Krzysztof Selmaj Lodz Poland
Klinički bolnički centar Rijeka (Clinical Hospital Center Rijeka) Rijeka Croatia
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Slagelse Hospital Slagelse Denmark
Hospital Universitario Virgen De Valme Sevilla Spain
St Vincent’s University Hospital Dublin Ireland
Military Medical Academy Pleven Bulgaria
Hospital Alvaro Cunqueiro Vigo Spain
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Hospital Universitario Puerta Del Mar Cadiz Spain
University Hospital Bratislava Bratislava Slovakia
Hospital Universitario De Getafe Getafe Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain

Other Sites

Site Name City Country Status
Area De Salud De Leon Y El Bierzo Leon Spain
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Noorderhart Pelt Belgium
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j. Piotrkow Trybunalski Poland
Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi Lodz Poland
Resmedica Sp. z o.o. Kielce Poland
Uahdmczfgnp npxwsdfvo Le Pulqwovl Kipvbh Kosice Slovakia
Fktasdis Nglzpkwwq Tiphxd Trnava Slovakia
Cdaecyep Sesysqia Ismwymxw L'hospitalet De Llobregat Spain
Minceylpaijv Heurqepv Fuh Aounap Ttgugpsrq Ij Nrgvyqfeq Ang Phetwkycda Saq Npao Efm Sofia Bulgaria
Nyvqef Sft z ouiw Rzeszow Poland
Lnwzypak Jhlre mdotvbcnu cntcxu Am Riga Latvia
Rhcaoohftoum Steilje lotvrgdt Vbgzq Siauliai Lithuania
Fzvkaaof Pplccom Cgjffx Barcelona Spain
Niwubxdsxprq Bvrctgedl Sem z ofof Bydgoszcz Poland
Umumgisuao Hrvvcrjt Slidp Dxv Zagreb Croatia
Kwmwqcebhyort Naluw sjwmui Nitra Slovakia
Nikosoali Mldnkzik Shtbyfca Ctltiud Vrjqmi Steenokkerzeel Belgium
Cpcbytt Mfvplqwy Ormjpf Wroclaw Poland
Efxchuavq Sxx z ouov Szczecin Poland
Mqqbnwyltldju Hwubuuhy fom Alcsxl Tjnmnmuum Hhyei asg Bdykv Erf Pleven Bulgaria
Ipuqcoulzyiv Povuyxzj Lekdjdqb Prjbo df hwgt nl mbzf Kogxrf Rmxiyy Lublin Poland

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
22.06.2022
Belgium Belgium
Not recruiting
22.06.2022
Bulgaria Bulgaria
Not recruiting
22.06.2022
Croatia Croatia
Not recruiting
22.06.2022
Denmark Denmark
Not recruiting
22.06.2022
Ireland Ireland
Not recruiting
22.06.2022
Italy Italy
Not recruiting
22.06.2022
Latvia Latvia
Not recruiting
22.06.2022
Lithuania Lithuania
Not recruiting
22.06.2022
Poland Poland
Not recruiting
22.06.2022
Slovakia Slovakia
Not recruiting
22.06.2022
Spain Spain
Not recruiting
22.06.2022
The Netherlands The Netherlands
Not recruiting
22.06.2022

Trial locations

Remibrutinib is a medication being studied for its potential to reduce the frequency of relapses in people with relapsing multiple sclerosis. It is being compared to another treatment to see if it is more effective in managing the symptoms of this condition.

Teriflunomide is a medication currently used to treat relapsing multiple sclerosis. It works by reducing inflammation and slowing down the immune system’s attack on the nervous system, which can help decrease the number of relapses experienced by patients.

Investigated Diseases:

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 covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, this can cause permanent damage or deterioration of the nerves themselves. The disease often presents with symptoms such as fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of Multiple Sclerosis can vary widely among individuals, with some experiencing mild symptoms and others facing more severe challenges. The course of the disease can include periods of relapses and remissions, or it may progress steadily over time.

Trial ID:
2023-509345-12-00
Protocol code:
CLOU064C12301
NCT ID:
NCT05147220
Trial Phase:
Therapeutic confirmatory (Phase III)

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