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 a new treatment for Multiple Sclerosis (MS), a condition that affects the brain and spinal cord, leading to a range of symptoms such as fatigue, difficulty walking, and vision problems. The study compares the effectiveness and safety of a medication called remibrutinib with another medication known as teriflunomide. Remibrutinib is a new drug that works by targeting specific proteins in the body to reduce inflammation, while teriflunomide is an existing treatment that helps to modulate the immune system and reduce inflammation.

The purpose of this study is to determine if remibrutinib is more effective than teriflunomide in reducing the frequency of relapses in people with relapsing forms of MS. Participants in the study will be randomly assigned to receive either remibrutinib, teriflunomide, or a placebo, which is a substance with no active medication. The study will begin with a period where participants receive either remibrutinib or teriflunomide, followed by an extended treatment phase where all participants will receive remibrutinib. This approach helps researchers understand the long-term effects of remibrutinib on MS.

Throughout the study, participants will take the medications orally, and their health will be monitored regularly to assess the impact of the treatments. The study aims to provide valuable information on how well remibrutinib works compared to teriflunomide and to ensure the safety of participants. By participating in this study, researchers hope to find a more effective treatment option for those living with relapsing MS.

1 randomization

Participants are randomly assigned to receive either remibrutinib or teriflunomide. This process ensures that each participant has an equal chance of receiving either treatment.

2 treatment phase

Participants receive their assigned treatment. If assigned to remibrutinib, the dosage is 100 mg in the form of a film-coated tablet, taken orally. If assigned to teriflunomide, the dosage is 14 mg in the form of a hard capsule, also taken orally.

The treatment is administered daily. The duration of this phase is not specified in the provided data.

3 monitoring and assessment

Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes tracking the annualized relapse rate (ARR) of confirmed relapses and other health indicators.

Additional assessments may include MRI scans to evaluate the number of new or enlarging T2 lesions, and blood tests to measure neurofilament light chain (NfL) concentration.

4 extended treatment phase

Participants may enter an extended treatment phase with open-label remibrutinib. This means all participants will receive remibrutinib regardless of their initial assignment.

The specific duration of this phase is not detailed in the provided data.

5 completion and follow-up

Upon completion of the treatment phases, participants may undergo final assessments to evaluate long-term outcomes and any potential side effects.

The trial is estimated to conclude by October 30, 2030.

Who Can Join the Study?

  • The patient must provide a signed informed consent before any assessments are done.
  • The patient must be between 18 and 55 years old.
  • The patient must have a diagnosis of RMS. RMS stands for Relapsing Multiple Sclerosis, which is a type of multiple sclerosis where symptoms come and go.
  • The patient must have had at least one of the following:
    • One documented relapse in the past year.
    • Two documented relapses in the past two years.
    • One active Gadolinium-enhancing lesion in the past year. This is a type of brain scan finding that shows active inflammation.
  • The patient must have an EDSS score between 0 and 5.5. The EDSS is a scale used to measure disability in people with multiple sclerosis.
  • The patient must be neurologically stable for at least one month before the screening and randomization. This means no new or worsening symptoms of multiple sclerosis 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 not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Centre Hospitalier Universitaire De Caen Normandie Caen France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centro Hospitalar E Universitario De Coimbra E.P.E. Coimbra Portugal
Hospital Clinico San Carlos Madrid Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero Universitaria Ospedali Riuniti Foggia Italy
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Lille Lille France
KBC Split Split Croatia
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Centre Hospitalier Universitaire De Nimes Nimes France
Universitaetsklinikum Essen AöR Essen Germany
Oncopole Claudius Regaud Toulouse France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Region Stockholm – SLSO Stockholm Sweden
CHU Grenoble Alpes La Tronche France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
KBC Zagreb Zagreb Croatia
Spitalul Clinic De Psihiatrie Si Neurologie Brasov Brasov Romania
Groupement Des Hopitaux De L’Institut Catholique De Lille Lomme France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Centre Hospitalier Et Universitaire De Limoges Limoges France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Centre Hospitalier Universitaire De Dijon Dijon France
Tartu University Hospital Tartu Estonia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Hospital Universitario Araba Vitoria Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
University Medical Center Ljubljana Ljubljana Slovenia
Hopital Europeen Marseille Marseille France
CHU Gabriel-Montpied Clermont Ferrand France
University Hospital Bratislava Bratislava Slovakia
Krajska zdravotni a.s. Teplice Czechia
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Henry Dunant Hospital Center Athens Greece
Opca Bolnica Varazdin Varazdin Croatia
Neuro-Medic Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Azienda Sanitaria Locale Di Taranto Taranto Italy
Fundeni Clinical Institute Bucharest Romania
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Pratia S.A. Skorzewo Poland
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen Siegen Germany
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Hospital General Universitario De Albacete Albacete Spain
Uyvkjkupte Gudhzzh Hifjckfl Os Iyikswal Ioannina Greece
Hou Sanldy Aiyw Toulon France
Mtqd Ndhekuas Hiewv Hireoluh Env Sofia Bulgaria
Mtcwm Bfkzx Dnmgloox nqligibxiwxj aijjupvwxl sjfvgz Banska Bystrica Slovakia
Nqwycitvmr mxtsxzrqecn bvtnzle Vbxikms Vukovar Croatia
Ethwvhf Gsojf Svavdu Scheia Romania
Wubpbxsqzxijhasypenm Cjkvkfc Mwblielk Ihyreze Suy Zabrze Poland
Kohzsj Muwln Kzodrdlehst Bialystok Poland
Cvgywuda Oa Tallin Estonia
Cijuxsg Mgcjhkbw Hcuc Cotleg Lublin Poland
Cbbknm Hrdnmwdwcfw Awrvz Lwpki 74130 France
Ihljvykc Nfymfnmjkin Mldgqrxhbmcj Nqjwkudg Shorrb Pozzilli Italy
Swrdguyo Cczazu Jxscheus Dr Ujlrytr Sijklqz Asurtdh Agewdx Cbdphvnou Constanta Romania
Hamrnwez Vtkiqe Psukqd Sqr Avunttq Malaga Spain
Sdf Ligbqfgreuir Hjtiymoc Smpo Thessaloniki Greece
Ejlwnibj Hercbksy Athens Greece
Ngbj Tdpmprtj Mvyhbrea Stbuyze Sfnrdklmxvouakn Ieeayvz Ssfupgw Ravlqng Syf z oonz Glogow Malopolski Poland
Sgjmpjqg Cqfuur Cop Ftcfkx Clcpzuqjj Constanta Romania
Ffrtorjhkb Irxzrtzs Ncmtdgdquny Nbomajjbr Cupysqnr Mpjqhqt Pavia Italy
Ukttpugrotjki Kyetlrwo Cmcscr Myrzqep Maribor Slovenia
Whijkoepa I Bzvomgaq A Smtjcqwgnczf sdcu Wroclaw Poland
Crhvqs Hhirfkfkyvz Gcbpwwh Gonesse France
Uplejba Lymam Di Snnne Db Eztks O Dwpfh E Vnlol Ership Santa Maria Da Feira Portugal
Ubwgzzm Libjv Dj Speaw Ds Mkrwjpktyz Ehdpnn Senhora Da Hora Portugal
Ntpaysagzb Gsssglmsbtzi fzo vmzzobhraqz Gjiqyjlhphsqagsej Ghip Ulm Germany
Ecnujsfop Ixnzyocjl Fnw Cvxxwohbahtlwn Dqktogio Axi Tlgegnibcj Targu Mures Romania
Mayinc Cjvgrpaa Sqk z owsy Katowice Poland
Sywhrrm Bkajxwsaxo Ceuvd Celje Slovenia
Ibaaz Czivxk Njlcqeweh Bpgjiy Phagll Messina Italy
Czituk Sahhfijgv Srncmq Campulung Romania
Nyolhzheua Spzwkm Cekuogw Mfrayyen Katowice Poland
Muzyybfe Sywgsily Ihbkrqmx fwia kpayzyumm Ssznnyy Gmz Hamburg Germany

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
20.06.2022
Croatia Croatia
Not recruiting
20.06.2022
Czechia Czechia
Not recruiting
20.06.2022
Estonia Estonia
Not recruiting
20.06.2022
France France
Not recruiting
20.06.2022
Germany Germany
Not recruiting
20.06.2022
Greece Greece
Not recruiting
20.06.2022
Italy Italy
Not recruiting
20.06.2022
Poland Poland
Not recruiting
20.06.2022
Portugal Portugal
Not recruiting
20.06.2022
Romania Romania
Not recruiting
20.06.2022
Slovakia Slovakia
Not recruiting
20.06.2022
Slovenia Slovenia
Not recruiting
20.06.2022
Spain Spain
Not recruiting
20.06.2022
Sweden Sweden
Not recruiting
20.06.2022

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 medication 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 sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. 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 be unpredictable, with periods of remission and relapses. The severity and specific symptoms can differ greatly from person to person.

Trial ID:
2023-509372-41-00
Protocol code:
CLOU064C12302
NCT ID:
NCT05156281
Trial Phase:
Therapeutic confirmatory (Phase III)

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