Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis

3 1 1

What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called tolebrutinib in people with different types of Multiple Sclerosis (MS). MS is a disease that affects the nervous system, and it can be categorized into several types, including relapsing multiple sclerosis (RMS), primary progressive multiple sclerosis (PPMS), and nonrelapsing secondary progressive multiple sclerosis (NRSPMS). The purpose of this study is to understand how safe and tolerable tolebrutinib is for people with these conditions over a long period.

Participants in this study will receive tolebrutinib, which is taken as a film-coated tablet, or a placebo. The study will also involve the use of another medication called Aubagio, which contains the active substance teriflunomide. Some participants may receive a placebo that matches the appearance of Aubagio. The study will monitor participants for any side effects or adverse events that may occur while taking these medications. Additionally, the study will track changes in the participants’ condition, such as the progression of disability or the rate of relapses in those with RMS.

The study will last for several years, allowing researchers to gather comprehensive data on the long-term effects of tolebrutinib. Participants will be regularly assessed to ensure their safety and to evaluate the effectiveness of the treatment. The study aims to provide valuable insights into the management of multiple sclerosis and to improve treatment options for those living with this condition.

1 joining the study

Upon joining the study, participants are required to have completed a previous Phase 2b or Phase 3 trial involving tolebrutinib. This ensures that participants have prior experience with the medication under investigation.

2 medication administration

Participants will receive tolebrutinib in the form of film-coated tablets. The medication is taken orally. The specific dosage and frequency will be determined by the study protocol and communicated to participants by the study team.

In some cases, participants may also receive a placebo, which is a substance with no active medication, to compare the effects of tolebrutinib.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess the long-term safety and tolerability of tolebrutinib. This includes tracking any adverse events or side effects experienced during the trial.

Participants may also undergo imaging tests, such as magnetic resonance imaging (MRI), to monitor changes in the brain and nervous system.

4 study duration

The study is designed to continue until August 30, 2029. Participants will be informed of their specific involvement duration, which may vary based on individual circumstances and study requirements.

5 end of study

At the conclusion of the study, participants will have a final assessment to evaluate the overall effects of the treatment. This will include a review of any adverse events and changes in their condition.

Participants will receive information about the study findings and any potential next steps regarding their treatment.

Who Can Join the Study?

  • Participants must have a type of multiple sclerosis, which is a disease affecting the nervous system. This includes relapsing multiple sclerosis (RMS), primary progressive multiple sclerosis (PPMS), or non-relapsing secondary progressive multiple sclerosis (NRSPMS).
  • Participants should have completed a specific earlier study, either the Phase 2b LTS (LTS16004) or one of the four Phase 3 tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035).
  • Participants who had to temporarily stop the study medication due to a national emergency but completed the trial visits can also join.
  • Both men and women are eligible to participate.
  • The study includes people who might be considered vulnerable, meaning they may need extra care or protection.

Who Cannot Join the Study?

  • Participants with any other serious health conditions that could interfere with the study.
  • Individuals who are currently participating in another clinical trial.
  • People who have had a recent infection that required treatment.
  • Anyone who has had a recent vaccination within a certain time frame before the study.
  • Individuals with a history of certain types of cancer.
  • Participants who are pregnant or breastfeeding.
  • People with a history of drug or alcohol abuse.
  • Individuals who have had an allergic reaction to similar medications.
  • Anyone with a condition that affects their ability to understand or follow study instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Hopitaux Universitaires Pitie Salpetriere Paris France
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Hospital Vall d’Hebron Barcelona Spain
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
University Hospital Ostrava Ostrava Czechia
Hospital Universitario da A Coruna A Coruna Galicia Spain
Fakultni nemocnice Motol a Homolka Prague Czechia
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Medical University Of Vienna Vienna Austria
Amsterdam UMC Amsterdam The Netherlands
Helse Bergen HF Bergen Norway
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Universitaetsklinikum Duesseldorf AöR Duesseldorf Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Sydvestjysk Sygehus Esbjerg Denmark
Turku University Hospital Turku Finland
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
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
Universitaetsklinikum Muenster AöR Munster Germany
Kepler Universitaetsklinikum GmbH Linz Austria
Justus-Liebig-Universitaet Giessen Giessen Germany
Hospices Civils De Lyon Lyon France
Sahlgrenska University Hospital-Vastra Gotalandsregionen Gothenburg Sweden
Centre Hospitalier Universitaire De Lille Lille France
Klinikum der Universitaet Muenchen AöR Munich Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Universitaetsklinikum Essen AöR Essen Germany
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Oslo Universitetssykehus HF Oslo Norway
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Amphia Hospital Breda The Netherlands
Hospital Universitario Y Politecnico La Fe Valencia Spain
Servei De Salut De Les Illes Balears Palma Spain
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Brasov Romania
Univerzitna Nemocnica Martin Martin Slovakia
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Region Stockholm – SLSO Stockholm Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University General Hospital Attikon Athens Greece
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Pauls Stradins Clinical University Hospital Riga Latvia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Fondation A De Rothschild Paris France
KBC Zagreb Zagreb Croatia
Centre Hospitalier Regional Universitaire Besançon France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Hospital Universitario De Cruces Barakaldo Spain
Centre Hospitalier Universitaire De Nice Nice France
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hospital Universitario Donostia Donostia / San Sebastian Spain
Klinikum Bayreuth GmbH Bayreuth Germany
University Of Pecs Pecs Hungary
Pirkanmaan hyvinvointialue Tampere Finland
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
CHU Gabriel-Montpied Clermont Ferrand France
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Stichting Martini Ziekenhuis Groningen The Netherlands
Charite Research Organisation GmbH Berlin Germany
San Camillo Forlanini Hospital Rome Italy
University Hospital Bratislava Bratislava Slovakia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Katholisches Klinikum Bochum gGmbH Bochum Germany
Krajska zdravotni a.s. Teplice Czechia
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Krajska Nemocnice T Bati a.s. Zlin Czechia
Neuro-Medic Sp. z o.o. Katowice Poland
Uno Medical Trials Kft. Budapest Hungary
Hospital Pedro Hispano Matosinhos Portugal

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Fundeni Clinical Institute Bucharest Romania
Clinexpert Kft. Budapest Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Athens Medical Center S.A. Athens Greece
Hopital Purpan Toulouse France
Centro Hospitalar Universitario Lisboa Central E.P.E. Lisbon Portugal
Noorderhart Pelt Belgium
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Szpital Wolski Im. Dr Anny Gostynskiej Sp. z o.o. Warsaw Poland
Centre Hospitalier Intercommunal De Poissy Saint Germain Poissy France
Upopbmjpxy Mdrlpcyydfdn Hluzslyv Fic Agyokl Tqhsrityx Apb Eotwimaiz Mbglwqwy N I Pezrapg Sofia Bulgaria
Hazbtcp Pvnztqqzenkvnowy Rpnpzr Rennes France
4vn Gwxtipx Mfneiwvn Hyojvrql Om Altzzl Athens Greece
Mhtlfrluples Hloqmaso Fqv Ajkset Turckfhhk Ij Ntdftmrrf Ayt Pqwpkecuqx Sxv Nrmp Elx Sofia Bulgaria
Snhkywmk Cdpymx Jvunvjmr Di Uibfgdp Bzkag Oradea Romania
Sdjcpblua Krpv Budapest Hungary
Rtlkrlxwfdkx Sfuruyl lqkmhmdb Vcbju Siauliai Lithuania
nhqmwjsxypqclkvvp Berlin Germany
Uqhhelrlvh Mnuslhxxhijh Hbezqnpt fsp Abfska Trnviegai Ssbwv Mhbqib &wcuesa Pcxgcu Pleven Bulgaria
Nyavsdcsawkcmt Frnunlsmwlcjisu Bdpwvz Berlin Germany
Cgrwgk Huikyahjrlh Uifrfqwjshfsf Dc Nkqsdt Saint-Herblain France
Cxaodj Hbetlmyczbf Rxgoepnv Ugfmmdzkstkew Dy Npecl Nancy France
Ivixknms Noakjvggcxx Mnezfrbwgzzs Nqhwccux Sbjgrp Pozzilli Italy
Rnrdga Mpeebbcfkdn Herning Denmark
Sfyqaprr Ckfdqm Jcfrqidd Dq Uisybtb Cbdb Cluj Napoca Romania
Sky Lagrlthwfsuc Hfypilgy Sjtp Thessaloniki Greece
Nykhsdjcllcb Bmjopgijx Scm z ocwm Bydgoszcz Poland
Eqafrepp Hnbjlsjh Athens Greece
Ackwftv Sdrmf Sfkuwewgx Lndbrv Nq 8 Dm Cuxevzcb Cagliari Italy
Nbqf Thrchvxg Mzgyklwo Ssymoiw Sdscwvomhvqttjv Idkvlna Swyplkk Reucxej Sqi z omaj Glogow Malopolski Poland
Apcl Cudked Syjbhv Sibiu Romania
Svguqkyv Cxddqe Coq Fgwvcy Crblgctnq Constanta Romania
Ldkegabz Juycc mxvkxqjrs cpbkda At Riga Latvia
Fqzwgfeuyx Icjajczf Nhbnsqxlckv Nyekbeiac Cpppbwva Mfwgkva Pavia Italy
Hinqkjbx Dn Slksm Mdonm Esimuq Lisbon Portugal
Kskwyokaepomn Nzztc suiahc Nitra Slovakia
Czjbct Hcfrnlhtdhm Gkixeip Gonesse France
Ucarpdv Lkxkw Dv Sarwt Dy Esjqg O Degny E Vgowi Ewlfzz Santa Maria Da Feira Portugal
Moxxpj Csuwefou Syj z ogvx Katowice Poland
Noulcksuwshz Sar z oldo Warsaw Poland
Clcttn Shjkyscbc Splkst Campulung Romania
Ikyzcgimfayf Przisdju Lcjwpyww Phdef dp hdfu nh mfgc Kmbkip Rmexzs Lublin Poland
Cxgxkzbj Oe Tallin Estonia
Miwzaxeb Spxawzm Hamburg Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.04.2024
Belgium Belgium
Recruiting
15.04.2024
Bulgaria Bulgaria
Recruiting
15.04.2024
Croatia Croatia
Recruiting
15.04.2024
Czechia Czechia
Recruiting
15.04.2024
Denmark Denmark
Recruiting
15.04.2024
Estonia Estonia
Recruiting
15.04.2024
Finland Finland
Not recruiting
15.04.2024
France France
Recruiting
15.04.2024
Germany Germany
Recruiting
15.04.2024
Greece Greece
Recruiting
15.04.2024
Hungary Hungary
Recruiting
15.04.2024
Italy Italy
Recruiting
15.04.2024
Latvia Latvia
Not recruiting
15.04.2024
Lithuania Lithuania
Not recruiting
15.04.2024
Norway Norway
Recruiting
15.04.2024
Poland Poland
Recruiting
15.04.2024
Portugal Portugal
Recruiting
15.04.2024
Romania Romania
Recruiting
15.04.2024
Slovakia Slovakia
Not recruiting
15.04.2024
Spain Spain
Recruiting
15.04.2024
Sweden Sweden
Recruiting
15.04.2024
The Netherlands The Netherlands
Recruiting
15.04.2024

Trial locations

Tolebrutinib is a medication being studied for its long-term safety and tolerability in people with multiple sclerosis. This includes those with relapsing forms of the disease, as well as those with primary progressive or nonrelapsing secondary progressive multiple sclerosis. The goal is to see how well patients can tolerate the medication over an extended period and to monitor any potential side effects.

Relapsing Multiple Sclerosis – This is a disease where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. It is characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. Over time, the disease can lead to a gradual worsening of symptoms and disability. The progression of the disease can vary greatly among individuals, with some experiencing frequent relapses and others having long periods of stability.

Progressive Multiple Sclerosis – This form of multiple sclerosis is marked by a steady worsening of neurological function from the onset of symptoms, without early relapses or remissions. It can be further classified into primary progressive multiple sclerosis, where symptoms gradually worsen from the start, and secondary progressive multiple sclerosis, which follows an initial relapsing-remitting course. The disease progression can lead to increasing disability over time. The rate of progression can vary, with some individuals experiencing a slow decline and others a more rapid deterioration.

Trial ID:
2023-503631-18-01
Protocol code:
LTS17043
Trial Phase:
Therapeutic confirmatory (Phase III)

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