Clinical trial • Phase III • Neurology
REMIBRUTINIB for Relapsing multiple sclerosis
Phase III trial of REMIBRUTINIB for Relapsing multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Relapsing multiple sclerosis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-05-2024
- First CTIS Authorization Date
- 20-06-2024
Trial design
Randomised, open-label, teriflunomide 14 mg orally once daily (comparator arm); double-dummy design with matching placebos (placebo to remibrutinib 100 mg film-coated tablet; placebo to teriflunomide 14 mg capsule, hard) as described in the protocol.-controlled Phase III trial in Denmark, Austria, Croatia and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Teriflunomide 14 mg orally once daily (comparator arm); double-dummy design with matching placebos (Placebo to Remibrutinib 100 mg film-coated tablet; Placebo to teriflunomide 14 mg capsule, hard) as described in the protocol.
- Target Sample Size
- 545
Eligibility
Recruits 545 Vulnerable population is selected. Signed informed consent is required: "Signed informed consent obtained prior to any assessment performed (confirm at screening visit)". Study includes subject information and informed consent forms and pregnancy follow-up documents; participants provide their own consent (no paediatric/assent procedures described)..
- Vulnerable Population
- Vulnerable population is selected. Signed informed consent is required: "Signed informed consent obtained prior to any assessment performed (confirm at screening visit)". Study includes subject information and informed consent forms and pregnancy follow-up documents; participants provide their own consent (no paediatric/assent procedures described).
Inclusion criteria
- {"criterion_text":"- Signed informed consent obtained prior to any assessment performed (confirm at screening visit)"}
- {"criterion_text":"- Male or female participants 18 to 55 years of age (inclusive) at screening"}
- {"criterion_text":"- Diagnosis of RMS according to the 2017 McDonald diagnostic criteria (this would include RRMS or active SPMS) as confirmed at screening visit"}
- {"criterion_text":"- At least: 1 documented relapse within the previous year, OR 2 documented relapses within the previous 2 years, prior to screening, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months prior to screening"}
- {"criterion_text":"- EDSS score of 0 to 5.5 (inclusive) at screening and randomization"}
- {"criterion_text":"- Neurologically stable within 1 month prior to screening and randomization (including no Multiple Sclerosis (MS) relapse in this period)"}
Exclusion criteria
- {"criterion_text":"- Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening"}
- {"criterion_text":"- Use of exclusionary medication prior to screening/randomization"}
- {"criterion_text":"- Requirement for anticoagulant medication (e.g. warfarin or Novel Anti-Coagulants (NOAC)) or use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel). The use of acetylsalicylic acid up to 100 mg/day or clopidogrel up to 75 mg/day is permitted"}
- {"criterion_text":"- Significant bleeding risk or coagulation disorders, at screening"}
- {"criterion_text":"- Have received any live or live-attenuated vaccines (including but not limited to varicella-zoster virus or measles, oral polio, nasal influenza) within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during study treatment"}
- {"criterion_text":"- History of clinically significant Central Nervous System (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at screening"}
- {"criterion_text":"- Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML prior to randomization"}
- {"criterion_text":"- Score “yes” on item 4 or item 5 of the suicidal ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if this ideation occurred in the past 6 months, or “yes” on any item of the suicidal behavior section, except for the “Non-Suicidal Self-Injurious Behavior” (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years, prior to randomization"}
- {"criterion_text":"- Participants who have had a splenectomy"}
- {"criterion_text":"- Active clinically significant systemic bacterial, viral, parasitic or fungal infections in the judgement of the investigator prior to randomization (e.g. infections requiring hospitalization or i.v. antibiotics)"}
- {"criterion_text":"- Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder"}
- {"criterion_text":"- Participants with a known immunodeficiency syndrome (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, drug induced immune deficiency), or tested positive for Human immunodeficiency virus (HIV) antibody, at screening"}
- {"criterion_text":"- Resting QT interval corrected by Fridericia’s formula (QTcF) ≥450 msec (male) or ≥460 msec (female) at pretreatment as per central ECG reading at screening visit"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Annualized relapse rate (ARR) of confirmed relapses","definition_or_measurement_approach":"Annualized relapse rate (ARR) of confirmed relapses (ARR calculated as the yearly rate of confirmed MS relapses)"}
Secondary endpoints
- {"endpoint_text":"- Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS)","definition_or_measurement_approach":"Time-to-event measured as time until 3-month confirmed disability progression on EDSS"}
- {"endpoint_text":"- Time to 6-month confirmed disability progression (6mCDP) on EDSS","definition_or_measurement_approach":"Time-to-event measured as time until 6-month confirmed disability progression on EDSS"}
- {"endpoint_text":"- Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate)","definition_or_measurement_approach":"Annualized count of new or enlarging T2 lesions on MRI"}
- {"endpoint_text":"- Total number of Gd-enhancing T1 lesions per MRI scan","definition_or_measurement_approach":"Count of Gadolinium-enhancing T1 lesions per MRI scan"}
- {"endpoint_text":"- Neurofilament light chain (NfL) concentration in serum","definition_or_measurement_approach":"Serum concentration measurement of neurofilament light chain (NfL)"}
- {"endpoint_text":"- Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI","definition_or_measurement_approach":"Composite endpoint assessing absence of confirmed relapses, 6mCDP and new/enlarging T2 lesions (NEDA-3)"}
- {"endpoint_text":"- Time to first confirmed relapse","definition_or_measurement_approach":"Time-to-event measured as time until first confirmed MS relapse"}
- {"endpoint_text":"- Time to 6-month confirmed disability improvement (6mCDI) on EDSS (pooled data)","definition_or_measurement_approach":"Time-to-event measured as time until 6-month confirmed disability improvement on EDSS (pooled data)"}
- {"endpoint_text":"- Time to 3mCDP and 6mCDP independent of relapse activity (PIRA, pooled data)","definition_or_measurement_approach":"Time-to-event PIRA endpoints (progression independent of relapse activity) using pooled data"}
- {"endpoint_text":"- Change from baseline in the Symbol Digit Modalities Test (SDMT) (pooled data)","definition_or_measurement_approach":"Change from baseline in SDMT score (cognitive measure), pooled data"}
- {"endpoint_text":"- Time to 6-month confirmed worsening by at least 20% in the: ● Timed 25-foot walk test (T25FW) (pooled data) ● Timed 9-hole peg test (9HPT) (pooled data)","definition_or_measurement_approach":"Time-to-event for confirmed ≥20% worsening sustained for 6 months in T25FW and 9HPT (pooled data)"}
- {"endpoint_text":"- Time to composite 6-month confirmed disability progression, as evaluated by 6mCDP or 6-month confirmed worsening by at least 20% in T25FW or 9HPT (pooled data)","definition_or_measurement_approach":"Composite time-to-event combining 6mCDP or confirmed ≥20% worsening in T25FW/9HPT (pooled data)"}
- {"endpoint_text":"- Change from baseline in T2 lesion volume","definition_or_measurement_approach":"Change from baseline in MRI-assessed T2 lesion volume"}
- {"endpoint_text":"- Multiple Sclerosis Impact Scale (MSIS-29)","definition_or_measurement_approach":"Patient-reported outcome measured by MSIS-29"}
- {"endpoint_text":"- Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating","definition_or_measurement_approach":"Safety assessments including AEs, labs, vitals, ECG and C-SSRS"}
- {"endpoint_text":"- Remibrutinib blood concentrations","definition_or_measurement_approach":"Pharmacokinetic measurement: remibrutinib plasma concentrations"}
- {"endpoint_text":"- Extension Part: ● Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating ● ARR, number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate), time to 6mCDP (EDSS), change in SDMT, NfL, Patient Reported Outcomes scores","definition_or_measurement_approach":"Long-term safety and efficacy assessments during extension (same measures as main study: safety, ARR, MRI, EDSS, SDMT, NfL, PROs)"}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 545
- Recruitment Window Months
- 100
- Consent Approach
- Signed informed consent is required: "Signed informed consent obtained prior to any assessment performed (confirm at screening visit)". Subject information and consent forms (L1) and optional/ancillary consent documents (genetics, pregnancy follow-up, partner follow-up) are provided. Consent documents are available in multiple country/language versions (examples in English, Croatian, Dutch, Spanish, German, Polish, Slovak, Bulgarian, French, Italian, Lithuanian, Latvian and Russian in the provided document list). Participants provide their own consent (no paediatric assent described).
Methods
- Country-specific recruitment arrangements and materials (K1/K2 recruitment documents present) including recruitment flyers, posters and study introduction multifolds (documents available for ES, HR, BE, NL, PL, LV, IT, SK, LT and others).
- Use of patient-facing recruitment materials and support provided by third parties (Jumo Health USA Inc. listed with duty: 'Recruitment and Patient facing materials').
- Pre-screening software services (Reify Health Inc. listed: 'Software services for pre-screening tool').
- Site-level recruitment support including informed consent flipcharts and GP letters (K2 and L2 documents present).
Geography
- Total Number Of Sites
- 67
- Total Number Of Participants
- 464
Denmark
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 19-05-2025
- Processing Time Days
- 356
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Slagelse Hospital
- Department Name
- Department of Neurology
- Principal Investigator Name
- Masoud Falah
- Principal Investigator Email
- masfa@regionsjaelland.dk
- Contact Person Name
- Masoud Falah
- Contact Person Email
- masfa@regionsjaelland.dk
Austria
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 538
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Department of Neurology
- Principal Investigator Name
- Gerhard Traxler
- Principal Investigator Email
- Gerhard.traxler@kepleruniklinikum.at
- Contact Person Name
- Gerhard Traxler
- Contact Person Email
- Gerhard.traxler@kepleruniklinikum.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Department of Neurology
- Principal Investigator Name
- Hamid Assar
- Principal Investigator Email
- hamid.assar@kepleruniklinikum.at
- Contact Person Name
- Hamid Assar
- Contact Person Email
- hamid.assar@kepleruniklinikum.at
Croatia
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 528
- Number Of Sites
- 4
- Number Of Participants
- 55
Sites
- Site Name
- Clinical Hospital Centre Rijeka
- Department Name
- #9005:Neurology
- Principal Investigator Name
- Vladimira Vuletić
- Principal Investigator Email
- vladimira.vuletic@gmail.com
- Contact Person Name
- Vladimira Vuletić
- Contact Person Email
- vladimira.vuletic@gmail.com
- Site Name
- University Hospital Sveti Duh
- Department Name
- #9008:Neurology
- Principal Investigator Name
- Sanja Tomasović
- Principal Investigator Email
- stomasovic98@gmail.com
- Contact Person Name
- Sanja Tomasović
- Contact Person Email
- stomasovic98@gmail.com
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- #9006:Neurology
- Principal Investigator Name
- Anamarija Soldo Koruga
- Principal Investigator Email
- anamarijasoldo@gmail.com
- Contact Person Name
- Anamarija Soldo Koruga
- Contact Person Email
- anamarijasoldo@gmail.com
- Site Name
- KBC Zagreb
- Department Name
- #9001:Neurology
- Principal Investigator Name
- Mario Habek
- Principal Investigator Email
- mario.habek@mef.hr
- Contact Person Name
- Mario Habek
- Contact Person Email
- mario.habek@mef.hr
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 535
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- 7001 : Neurology
- Principal Investigator Name
- Melissa Cambron
- Principal Investigator Email
- melissa.cambron@azsintjan.be
- Contact Person Name
- Melissa Cambron
- Contact Person Email
- melissa.cambron@azsintjan.be
- Site Name
- Antwerp University Hospital
- Department Name
- 9111 : Neurology
- Principal Investigator Name
- Barbara Willekens
- Principal Investigator Email
- barbara.willekens@uza.be
- Contact Person Name
- Barbara Willekens
- Contact Person Email
- barbara.willekens@uza.be
- Site Name
- Hopital Erasme
- Department Name
- 9115 : Neurology
- Principal Investigator Name
- Sophie Elands
- Principal Investigator Email
- Sophie.elands@erasme.ulb.ac.be
- Contact Person Name
- Sophie Elands
- Contact Person Email
- Sophie.elands@erasme.ulb.ac.be
- Site Name
- Nationaal Multiple Sclerose Centrum V.Z.W.
- Department Name
- 7005 : Neurology
- Principal Investigator Name
- Marie D’Hooghe
- Principal Investigator Email
- marie.dhooghe@mscenter.be
- Contact Person Name
- Marie D’Hooghe
- Contact Person Email
- marie.dhooghe@mscenter.be
- Site Name
- Noorderhart
- Department Name
- 9112 : Neurology
- Principal Investigator Name
- Bart Van Wijmeersch
- Principal Investigator Email
- bart.vanwijmeersch@uhasselt.be
- Contact Person Name
- Bart Van Wijmeersch
- Contact Person Email
- bart.vanwijmeersch@uhasselt.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 522
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- 1801: Neurology
- Principal Investigator Name
- Luuk Van Rooij
- Principal Investigator Email
- RooijL@maasstadziekenhuis.nl
- Contact Person Name
- Luuk Van Rooij
- Contact Person Email
- RooijL@maasstadziekenhuis.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 528
- Number Of Sites
- 10
- Number Of Participants
- 160
Sites
- Site Name
- Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi
- Department Name
- 1912: Oddział Neurologiczny i Oddział Udarowy
- Principal Investigator Name
- Tomasz Berkowicz
- Principal Investigator Email
- berkowt@gmail.com
- Contact Person Name
- Tomasz Berkowicz
- Contact Person Email
- berkowt@gmail.com
- Site Name
- Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
- Department Name
- 1908: IRMED
- Principal Investigator Name
- Beata Telatyńska-Maciejczyk
- Principal Investigator Email
- neurolog@ir-med.pl
- Contact Person Name
- Beata Telatyńska-Maciejczyk
- Contact Person Email
- neurolog@ir-med.pl
- Site Name
- Centrum Neurologii Krzysztof Selmaj
- Department Name
- 1903
- Principal Investigator Name
- Krzysztof Selmaj
- Principal Investigator Email
- kselmaj@gmail.com
- Contact Person Name
- Krzysztof Selmaj
- Contact Person Email
- kselmaj@gmail.com
- Site Name
- Nmedis Sp. z o.o.
- Department Name
- 1907
- Principal Investigator Name
- Iwona Rościszewska-Żukowska
- Principal Investigator Email
- iwona.rosciszewska@op.pl
- Contact Person Name
- Iwona Rościszewska-Żukowska
- Contact Person Email
- iwona.rosciszewska@op.pl
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- 1906
- Principal Investigator Name
- Karolina Piasecka – Stryczyńska
- Principal Investigator Email
- badania.kliniczne@medpolonia.pl
- Contact Person Name
- Karolina Piasecka – Stryczyńska
- Contact Person Email
- badania.kliniczne@medpolonia.pl
- Site Name
- Euromedis Sp. z o.o.
- Department Name
- 1910: Centrum Medyczne EuroMedis
- Principal Investigator Name
- Marcin Ratajczak
- Principal Investigator Email
- marcin.ratajczak@euromedis.pl
- Contact Person Name
- Marcin Ratajczak
- Contact Person Email
- marcin.ratajczak@euromedis.pl
- Site Name
- Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
- Department Name
- 1914
- Principal Investigator Name
- Konrad Rejdak
- Principal Investigator Email
- rejdakk@gmail.com
- Contact Person Name
- Konrad Rejdak
- Contact Person Email
- rejdakk@gmail.com
- Site Name
- Neurocentrum Bydgoszcz Sp. z o.o.
- Department Name
- 1901
- Principal Investigator Name
- Robert Bonek
- Principal Investigator Email
- r.bonek@ncbydgoszcz.pl
- Contact Person Name
- Robert Bonek
- Contact Person Email
- r.bonek@ncbydgoszcz.pl
- Site Name
- Centrum Medyczne Oporow
- Department Name
- 1913
- Principal Investigator Name
- Alina Niedzielska
- Principal Investigator Email
- alina.niedzielska@cmoporow.com
- Contact Person Name
- Alina Niedzielska
- Contact Person Email
- alina.niedzielska@cmoporow.com
- Site Name
- Resmedica Sp. z o.o.
- Department Name
- 1902
- Principal Investigator Name
- Elżbieta Jasińska
- Principal Investigator Email
- ejasinska6@gmail.com
- Contact Person Name
- Elżbieta Jasińska
- Contact Person Email
- ejasinska6@gmail.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 522
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- St Vincent's University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Christopher McGuigan
- Principal Investigator Email
- C.McGuigan@svhg.ie
- Contact Person Name
- Christopher McGuigan
- Contact Person Email
- C.McGuigan@svhg.ie
- Site Name
- St James's Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Hugh Kearney
- Principal Investigator Email
- KEARNEYH@tcd.ie
- Contact Person Name
- Hugh Kearney
- Contact Person Email
- KEARNEYH@tcd.ie
Latvia
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 522
- Number Of Sites
- 2
- Number Of Participants
- 19
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- 1601
- Principal Investigator Name
- Alina Flintere-Flinte
- Principal Investigator Email
- alina-medi@inbox.lv
- Contact Person Name
- Alina Flintere-Flinte
- Contact Person Email
- alina-medi@inbox.lv
- Site Name
- Latvijas Juras medicinas centrs AS
- Department Name
- 1602
- Principal Investigator Name
- Jolanta Kalnina
- Principal Investigator Email
- jolanta@ljmc.lv
- Contact Person Name
- Jolanta Kalnina
- Contact Person Email
- jolanta@ljmc.lv
Spain
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 559
- Number Of Sites
- 20
- Number Of Participants
- 83
Sites
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- #2312:servicio de neurología
- Principal Investigator Name
- Laura Borrega Canelo
- Principal Investigator Email
- laura.borrega@salud.madrid.org
- Contact Person Name
- Laura Borrega Canelo
- Contact Person Email
- laura.borrega@salud.madrid.org
- Site Name
- Hospital Nisa Sevilla Aljarafe
- Department Name
- #2317:servicio de neurología
- Principal Investigator Name
- Maria Dolores Paramo Camino
- Principal Investigator Email
- draparamo@gmail.com
- Contact Person Name
- Maria Dolores Paramo Camino
- Contact Person Email
- draparamo@gmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- #2307:servicio de neurología
- Principal Investigator Name
- Ana Maria Lopez Real
- Principal Investigator Email
- analr_2000@yahoo.com
- Contact Person Name
- Ana Maria Lopez Real
- Contact Person Email
- analr_2000@yahoo.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- #2316:servicio de neurología
- Principal Investigator Name
- Rosario Blasco Quilez
- Principal Investigator Email
- charoblascoquilez@yahoo.es
- Contact Person Name
- Rosario Blasco Quilez
- Contact Person Email
- charoblascoquilez@yahoo.es
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- #2319:servicio de neurología
- Principal Investigator Name
- Ines Gonzalez Suarez
- Principal Investigator Email
- ines.maria.gonzalez.suarez@sergas.es
- Contact Person Name
- Ines Gonzalez Suarez
- Contact Person Email
- ines.maria.gonzalez.suarez@sergas.es
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- #2323:servicio de neurología
- Principal Investigator Name
- Nieves Tellez Lara
- Principal Investigator Email
- tellezlara@gmail.com
- Contact Person Name
- Nieves Tellez Lara
- Contact Person Email
- tellezlara@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- #2303:servicio de neurología
- Principal Investigator Name
- Jose Meca Lallana
- Principal Investigator Email
- pmecal@gmail.com
- Contact Person Name
- Jose Meca Lallana
- Contact Person Email
- pmecal@gmail.com
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- #2321:servicio de neurología
- Principal Investigator Name
- Mercedes Romera Tellado
- Principal Investigator Email
- romera.neu@gmail.com
- Contact Person Name
- Mercedes Romera Tellado
- Contact Person Email
- romera.neu@gmail.com
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- #2315:servicio de neurología
- Principal Investigator Name
- Raul Espinosa Rosso
- Principal Investigator Email
- raul.espinosa.sspa@juntadeandalucia.es
- Contact Person Name
- Raul Espinosa Rosso
- Contact Person Email
- raul.espinosa.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- #2318:servicio de neurología
- Principal Investigator Name
- Francisco Gascon Gimenez
- Principal Investigator Email
- fgascongimenez@gmail.com
- Contact Person Name
- Francisco Gascon Gimenez
- Contact Person Email
- fgascongimenez@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- #2309:servicio de neurología
- Principal Investigator Name
- Aida Orviz Garcia
- Principal Investigator Email
- aida.orviz@gmail.com
- Contact Person Name
- Aida Orviz Garcia
- Contact Person Email
- aida.orviz@gmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- #2311:servicio de neurología
- Principal Investigator Name
- Santiago Diaz Nicolas
- Principal Investigator Email
- sdianic80@gmail.com
- Contact Person Name
- Santiago Diaz Nicolas
- Contact Person Email
- sdianic80@gmail.com
- Site Name
- Hospital Santa Caterina Ias
- Department Name
- #2304:servicio de neurología
- Principal Investigator Name
- Luis Ramio Torrenta
- Principal Investigator Email
- llramio@idibgi.org
- Contact Person Name
- Luis Ramio Torrenta
- Contact Person Email
- llramio@idibgi.org
- Site Name
- Area De Salud De Leon Y El Bierzo
- Department Name
- #2310:servicio de neurología
- Principal Investigator Name
- Luis Enrique Hernandez Echebarria
- Principal Investigator Email
- lhernandezech@gmail.com
- Contact Person Name
- Luis Enrique Hernandez Echebarria
- Contact Person Email
- lhernandezech@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- #2320:servicio de neurología
- Principal Investigator Name
- Virginia Meca Lallana
- Principal Investigator Email
- virmeca@hotmail.com
- Contact Person Name
- Virginia Meca Lallana
- Contact Person Email
- virmeca@hotmail.com
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- #2308:servicio de neurología
- Principal Investigator Name
- Eduardo Aguera Morales
- Principal Investigator Email
- doctoredu@gmail.com
- Contact Person Name
- Eduardo Aguera Morales
- Contact Person Email
- doctoredu@gmail.com
- Site Name
- Fundacio Privada Cemcat
- Department Name
- #2301:Servicio de Neuroinmunología
- Principal Investigator Name
- Xavier Montalban Gairin
- Principal Investigator Email
- xmontalban@cem-cat.org
- Contact Person Name
- Xavier Montalban Gairin
- Contact Person Email
- xmontalban@cem-cat.org
- Site Name
- Consorci Sanitari Integral
- Department Name
- #2313: servicio de neurología
- Principal Investigator Name
- Ester Moral Torres
- Principal Investigator Email
- ester.moral@sanitatintegral.org
- Contact Person Name
- Ester Moral Torres
- Contact Person Email
- ester.moral@sanitatintegral.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- #2314:servicio de neurología
- Principal Investigator Name
- Lucienne Costa Frossard Franca
- Principal Investigator Email
- lufrossard@yahoo.es
- Contact Person Name
- Lucienne Costa Frossard Franca
- Contact Person Email
- lufrossard@yahoo.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- #2322:servicio de neurología
- Principal Investigator Name
- Carlos De La Cruz Cosme
- Principal Investigator Email
- carlosdelacruzcosme@gmail.com
- Contact Person Name
- Carlos De La Cruz Cosme
- Contact Person Email
- carlosdelacruzcosme@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 524
- Number Of Sites
- 6
- Number Of Participants
- 53
Sites
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- 8002: Clinic of Neurological Diseases for Movement Disorders
- Principal Investigator Name
- Ivan Milanov
- Principal Investigator Email
- ubalnp@yahoo.com
- Contact Person Name
- Ivan Milanov
- Contact Person Email
- ubalnp@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- 8001: Neurology Clinic
- Principal Investigator Name
- Maya Danovska-Mladenova
- Principal Investigator Email
- mdanovska@yahoo.com
- Contact Person Name
- Maya Danovska-Mladenova
- Contact Person Email
- mdanovska@yahoo.com
- Site Name
- Medical Center Medconsult Pleven OOD
- Department Name
- 8005:
- Principal Investigator Name
- Alim Izmaylov
- Principal Investigator Email
- alim_bg@yahoo.com
- Contact Person Name
- Alim Izmaylov
- Contact Person Email
- alim_bg@yahoo.com
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Department Name
- 8006:
- Principal Investigator Name
- Krasimir Genov
- Principal Investigator Email
- kr_genov@abv.bg
- Contact Person Name
- Krasimir Genov
- Contact Person Email
- kr_genov@abv.bg
- Site Name
- Military Medical Academy
- Department Name
- 8004: Clinic of Neurological Diseases
- Principal Investigator Name
- Stratina Stratieva
- Principal Investigator Email
- stratina@abv.bg
- Contact Person Name
- Stratina Stratieva
- Contact Person Email
- stratina@abv.bg
- Site Name
- Alexandrovska University Hospital
- Department Name
- 8003: Clinic of Neurology Diseases
- Principal Investigator Name
- Ivaylo Tarnev
- Principal Investigator Email
- itournev@gmail.com
- Contact Person Name
- Ivaylo Tarnev
- Contact Person Email
- itournev@gmail.com
Lithuania
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 523
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Respublikine Siauliu ligonine VšĮ
- Department Name
- Neurology department
- Principal Investigator Name
- Andrius Kazlauskas
- Principal Investigator Email
- andrius.kazlauskas@siauliuligonine.lt
- Contact Person Name
- Andrius Kazlauskas
- Contact Person Email
- andrius.kazlauskas@siauliuligonine.lt
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- Neurology center
- Principal Investigator Name
- Lina Malciene
- Principal Investigator Email
- lina.malciene@kulig.lt
- Contact Person Name
- Lina Malciene
- Contact Person Email
- lina.malciene@kulig.lt
Italy
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 529
- Number Of Sites
- 8
- Number Of Participants
- 22
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- 1503 : U.O. di Neurologia Centro di Riferimento Regionale Sclerosi Multipla
- Principal Investigator Name
- Cinzia Cordioli
- Principal Investigator Email
- cinzia.cordioli@gmail.com
- Contact Person Name
- Cinzia Cordioli
- Contact Person Email
- cinzia.cordioli@gmail.com
- Site Name
- Universita' Degli Studi Di Roma Tor Vergata
- Department Name
- 1504 : U.O.S.D. Centro di Riferimento Regionale per la Sclerosi Multipla
- Principal Investigator Name
- Girolama Alessandra Marfia
- Principal Investigator Email
- marfia@uniroma2.it
- Contact Person Name
- Girolama Alessandra Marfia
- Contact Person Email
- marfia@uniroma2.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- 1506 : U.O.C. Neurologia B
- Principal Investigator Name
- Massimiliano Calabrese
- Principal Investigator Email
- massimiliano.calabrese@univr.it
- Contact Person Name
- Massimiliano Calabrese
- Contact Person Email
- massimiliano.calabrese@univr.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- 1502:Dipartimento di Neuroscienze Scienze Riproduttive ed Odontostomatologiche Centro Sclerosi Multi
- Principal Investigator Name
- Vincenzo Brescia Morra
- Principal Investigator Email
- vincenzo.bresciamorra2@unina.it
- Contact Person Name
- Vincenzo Brescia Morra
- Contact Person Email
- vincenzo.bresciamorra2@unina.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- 1505 : U.O.C. Neurologia - Centro Sclerosi Multipla
- Principal Investigator Name
- Massimiliano Mirabella
- Principal Investigator Email
- massimiliano.mirabella@unicatt.it
- Contact Person Name
- Massimiliano Mirabella
- Contact Person Email
- massimiliano.mirabella@unicatt.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- 1501 : Dipartimento di Neurologia Centro Sclerosi Multipla
- Principal Investigator Name
- Massimo Filippi
- Principal Investigator Email
- filippi.massimo@hsr.it
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- 1508 : SCDU Neurologia - Dipartimento Medico
- Principal Investigator Name
- Domizia Vecchio
- Principal Investigator Email
- neurologi.segre@maggioreosp.novara.it
- Contact Person Name
- Domizia Vecchio
- Contact Person Email
- neurologi.segre@maggioreosp.novara.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- 1509 : U.O.C. Neurologia
- Principal Investigator Name
- Marco Salvetti
- Principal Investigator Email
- Marco.salvetti@uniroma1.it
- Contact Person Name
- Marco Salvetti
- Contact Person Email
- Marco.salvetti@uniroma1.it
Slovakia
- Earliest CTIS Part Ii Submission Date
- 28-05-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 522
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- University Hospital Bratislava
- Department Name
- 2202:Neurologická klinika SZU a UNB
- Principal Investigator Name
- Viera Hančinová
- Principal Investigator Email
- dr.hancinova@gmail.com
- Contact Person Name
- Viera Hančinová
- Contact Person Email
- dr.hancinova@gmail.com
- Site Name
- Univerzitna nemocnica L. Pasteura Kosice
- Department Name
- 2203:Neurologická klinika
- Principal Investigator Name
- Miriam Fedičova
- Principal Investigator Email
- miriam.fedicova@gmail.com
- Contact Person Name
- Miriam Fedičova
- Contact Person Email
- miriam.fedicova@gmail.com
- Site Name
- Fakultna Nemocnica Trnava
- Department Name
- 2201:Neurologické oddelenie
- Principal Investigator Name
- Georgi Krastev
- Principal Investigator Email
- georgi.krastev@fntt.sk
- Contact Person Name
- Georgi Krastev
- Contact Person Email
- georgi.krastev@fntt.sk
- Site Name
- Fakultna Nemocnica Nitra
- Department Name
- 2204:Neurologická klinika
- Principal Investigator Name
- Gabriel Hajaš
- Principal Investigator Email
- hajas.gabo@gmail.com
- Contact Person Name
- Gabriel Hajaš
- Contact Person Email
- hajas.gabo@gmail.com
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Name
- Syneos Health Inc.
- Name
- Icon Clinical Research Limited
- Responsibilities
- Supply management, clinical operations and other study services (multiple codes listed; including supply management and monitoring duties)
- Name
- IQVIA Limited
- Responsibilities
- Provision of ECG machines to site and ECG analysis/review; data services
- Name
- Signant Health Global LLC
- Responsibilities
- Provision of electronic tablet & hand held devices for patient data capture
Third parties
- {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local drug supply and affixing label","organisation_type":"Pharmaceutical company"}
- {"country":"Latvia","full_name":"E. Gulbja Laboratorija","duties_or_roles":"","organisation_type":"Health care"}
- {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Software services for pre-screening tool","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"EDSS licensing and consultancy","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Recruitment and Patient facing materials","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Provision of electronic tablet & hand held devices for patient data capture","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"MRI Imaging central review","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"SGS France","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple duties including supply management, monitoring, data-related functions (codes include 1,11,12,15 and others as listed)","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Novartis Poland Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited (alternate entry)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Provision of ECG machines to site and ECG analysis/review; other data/services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Provision of ancillary supplies","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO licensing and translation services","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- LOU064 (Remibrutinib)
- Active Substance
- REMIBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 1
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg twice daily (as described in protocol full title)
- Frequency
- Twice daily
- Investigational Product Name
- TERIFLUNOMIDE
- Active Substance
- TERIFLUNOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 2
- Starting Dose
- 14 mg
- Dose Levels
- 14 mg once daily
- Frequency
- Once daily
- Maximum Dose
- 14 mg/day
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