A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 18 años - 60 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 705 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- 18 to 60 years of age, inclusive
- Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria
- Participant must have documented evidence of disability progression observed during the 24 months before screening.
- Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.
Exclusion Criteria:
- Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.
- History or current diagnosis of other neurological disorders that may mimic MS
- History of any other significant active medical condition
- History of suicidal behavior within 6 months prior to Screening
- Any prior history of malignancy if no recurrence within 5 years
- Patients on anticoagulation, or antiplatelet therapy will be excluded
- Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days
- Clinically significant laboratory abnormalities at Screening.
- Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention
- Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
- History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Orelabrutinib Group
No informado en este registro.
Drug: Orelabrutinib
Placebo Group
No informado en este registro.
Drug: Placebo
Orelabrutinib DRUG
Orally
Placebo DRUG
Orally
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
Plazo: Up to approximately 120 weeks
- Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0, OR
- ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR
- ≥ 20% increase in the 9-hole Peg Test (9HPT)
Medidas secundarias
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP)
Plazo: Up to approximately 120 weeks
No informado en este registro.
Time to onset of confirmed disability progression (CDP) , confirmed over at least 24 weeks (24-week CDP)
Plazo: Up to approximately 120 weeks
Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0.
MRI T2 lesion
Plazo: Up to approximately 120 weeks
The total number of new/enlarging T2 lesions on MRI scans of the brain from baseline to Week 120
12-week CDP
Plazo: Up to approximately 120 weeks
Time to onset of CDP, confirmed over at least 12 weeks
Time to onset of CDP defined as ≥ 20% increase on 9-hole Peg Test (9HPT) from baseline, confirmed over at least 12 weeks (12-week CDP-9HPT)
Plazo: Up to approximately 120 weeks
No informado en este registro.
Time to onset of CDP defined as ≥ 20% increase on Timed 25-Foot Walk Test (T25FWT) from baseline, confirmed over at least 12 weeks (12-week CDP-T25FWT)
Plazo: Up to approximately 120 weeks
No informado en este registro.
24-week cCDI
Plazo: Up to approximately 120 weeks
Time to onset of composite confirmed disability improvement (cCDI) events, confirmed over at least 24 weeks
24-week CDI-9HPT
Plazo: Up to approximately 120 weeks
Time to onset of CDI on 9HPT defined as ≥ 20% decrease on the 9HPT score from baseline, confirmed over at least 24 weeks
24-week CDI
Plazo: Up to approximately 120 weeks
Time to onset of CDI on EDSS confirmed over at least 24 weeks
24-week CDI-T25FWT
Plazo: Up to approximately 120 weeks
Time to onset of CDI on T25FWT defined as ≥ 20% decrease on the T25FWT score from baseline, confirmed over at least 24 weeks
SDMT
Plazo: Up to approximately 120 weeks
The change in cognitive function as assessed by Symbol Digit Modalities Test (SDMT)
AEs
Plazo: Up to approximately 120 weeks
Safety as assessed by the nature, severity, and incidence of adverse events (AEs) (graded according to National Cancer Institute-Common Terminology Criteria for AEs, NCI-CTCAE version 5.0); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameter
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (86)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
86 centros
Arizona Neuroscience Research, LLCPheonix, Arizona, United StatesReclutando
Perseverance Research CenterScottsdale, Arizona, United StatesReclutando
Regina Berkovich MD, PhD Inc.West Hollywood, California, United StatesReclutando
Nova Clinical Research, LLCBradenton, Florida, United StatesReclutando
Neurology Associates, PAMaitland, Florida, United StatesReclutando
Neurological Services of OrlandoOrlando, Florida, United StatesReclutando
University of South Florida Department of Neurology - MS DivisionTampa, Florida, United StatesReclutando
University of Kansas Medical CenterKansas City, Kansas, United StatesReclutando
KC Research Center, PA Neurology Research DepartmentRoeland Park, Kansas, United StatesReclutando
Washington University School of MedicineSt Louis, Missouri, United StatesReclutando
Cooperman Barnabas Medical CenterLivingston, New Jersey, United StatesReclutando
Velocity Clinical Research, Raleigh NeurologyRaleigh, North Carolina, United StatesReclutando
The Ohio State University Wexner Medical Center (OSUWMC)Columbus, Ohio, United StatesReclutando
The Boster Center for Multiple SclerosisColumbus, Ohio, United StatesReclutando
Premier NeurologyGreenville, South Carolina, United StatesReclutando
Neurology Clinic, P.C.Cordova, Tennessee, United StatesReclutando
Lone Star NeurologySan Antonio, Texas, United StatesReclutando
Texas Institute for Neurological Disorders - ShermanSherman, Texas, United StatesReclutando
Medical College of WisconsinMilwaukee, Wisconsin, United StatesReclutando
Neurology NetworkMelbourne, AustraliaReclutando
UMHAT Dr Georgi StranskiPleven, Pleven, BulgariaReclutando
Medical Center NevrocentrumPlovdiv, Plovdiv, BulgariaReclutando
Diagnostic and Consultative Center ConvexSofia, Sofia, BulgariaReclutando
Medical Center Medica Plus OODVeliko Tarnovo, Tarnovo, BulgariaReclutando
Avis Medica Hospital PlevenPleven, BulgariaReclutando
DCC Neoclinic - SofiaSofia, BulgariaReclutando
Medical Center Hera EOODSofia, BulgariaReclutando
UBC Hospital, University Of British ColumbiaVancouver, British Columbia, CanadaReclutando
Klinicki Bolnicki Centar Zagreb-RebroZagreb, CroatiaReclutando
NEUROHK, s.r.o.Choceň, CzechiaReclutando
Fakultni Nemocnice Hradec KraloveHradec Králové, CzechiaReclutando
Nemocnice TepliceTeplice, CzechiaReclutando
Astra Clinic (Clinic4U)Tallinn, Harju, EstoniaReclutando
MD Georgia Staff Physician MediClub GeorgiaTbilisi, Saburtalo, GeorgiaReclutando
LTD Pineo Medical EcosystemTbilisi, GeorgiaReclutando
NNLE Jo Ann University HospitalTbilisi, GeorgiaReclutando
Caucasus Medical Center LtdTbilisi, GeorgiaReclutando
Raymann, LLCTbilisi, GeorgiaReclutando
Zentrum fur klinische Forschung Dr.Scholl GmbHBad Homburg, Hesse, GermanyReclutando
Neuro Centrum Science Gmbh Albert-SchwitzerErbach im Odenwald, Hesse, GermanyReclutando
IRCCS Istituto Neurologico Mediterraneo NeuromedPozzilli, Isemiaa/Molise, ItalyReclutando
Az. Osp.Universitaria Policlinico Federico II Centro Sclerosi Multipla Dip. Scienze NeurologicheNaples, Naples, ItalyReclutando
ARNAS Ospedali Civico Di CristinaPalermo, Sicily, ItalyReclutando
Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Clinica di Malattie dell'Apparato Respiratorio Neurologia & CRESMOrbassano, Torino, ItalyReclutando
University G. D'Annunzio of Chieti-PescaraChieti, ItalyReclutando
Zuyderland Medisch Centrum - Sittard-GeleenSittard, Limburg, NetherlandsReclutando
Centrum Medyczne INTERCOR Sp. z o.o.Bydgoszcz, Kuyavian-Pomeranian Voivodeship, PolandReclutando
Malva TrialsLublin, Lublin Voivodeship, PolandReclutando
Twoja Przychodnia Centrum Medyczne Nowa SolNowa Sól, Lubusz Voivodeship, PolandReclutando
ClinHouse Centrum MedyczneZabrze, Pl-sl, PolandReclutando
Centrum Medyczne Pratia KatowiceKatowice, Silesian Voivodeship, PolandReclutando
NZOZ Novo MedKatowice, Silesian Voivodeship, PolandReclutando
Neuro Medic ClinicKatowice, Upper Silesia, PolandReclutando
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki HertmanowskiejPlewiska, Wielkopolska, PolandReclutando
Twoja Przychodnia PCMPoznan, Wielkopolska, PolandReclutando
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska LekarzyPoznan, Wielkopolska, PolandReclutando
Copernicus Podmiot Leczniczy Szpital im. M. KopernikaGdansk, PolandReclutando
Galen ClinicLublin, PolandReclutando
NZOZ Neuromed M. i M. Nastaj Sp.PLublin, PolandReclutando
Nmedis sp.z o.o.Rzeszów, PolandReclutando
Euromedis Osrodek Badan KlinicznychSzczecin, PolandReclutando
Centrum Medyczne NeuroProtectWarsaw, PolandReclutando
MTZ Clinical Researcz Powered by pratiaWarsaw, PolandReclutando
Centrum Medyczne ProNeuro ŻoryŻory, PolandReclutando
Caribbean Center for Clinical ResearchGuaynabo, Puerto RicoReclutando
Clinical Hospital of Psychiatry and NeurologyBrasov, Brașov County, RomaniaReclutando
Spital Clinic CF ConstantaConstanța, Constanța County, RomaniaReclutando
Spitalul Clinic Judetean MuresTârgu Mureş, Mureș County, RomaniaReclutando
Clinical Centre Kragujevac, Neurology clinicKragujevac, Serbia, SerbiaReclutando
University Clinical Centre of SerbiaBelgrade, SerbiaReclutando
University Clinical Centre of KragujevacKragujevac, SerbiaReclutando
Clinic of Neurology - Clinical Center NisNiš, SerbiaReclutando
Mudr. Beata Dupejova, neurologická ambulancia S.R.O.Banská Bystrica, Slovakia, SlovakiaReclutando
Hospital Alvaro CunqueiroVigo, Galicia, SpainReclutando
Hospital Universitario 12 de OctubreMadrid, Madrid, SpainReclutando
Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, Madrid, SpainReclutando
Hospital Vithas Nisa SevillaCastilleja de la Cuesta, Seville, SpainReclutando
Complejo Hospitalario Universitario A CorunaA Coruña, SpainReclutando
Hospital Gregorio MarañonMadrid, SpainReclutando
Regional Municipal Non-commercial Enterprise Chernivtsi Emergency Medical HospitalChernivtsi, UkraineReclutando
CNE City Clinical Hospital #1 of Ivano-Frankivsk councilIvano-Frankivsk, UkraineReclutando
Neuro GlobalIvano-Frankivsk, UkraineReclutando
Limited Liability Company Medical Center NeuroclinicLviv, UkraineReclutando
Lviv National Medical University named after Danylo GalytskiyLviv, UkraineReclutando
Limited Liability Company "Neurofocus"Lviv, UkraineReclutando
Medical Clinical Investigational Center of Medical Center LLC Health ClinicVinnytsia, UkraineReclutando
Equipo y fechas
- Patrocinador principal
- Zenas BioPharma (USA), LLC
- Inicio del estudio
- 23 mar 2026 Real
- Finalización primaria
- 2030-06 Estimado
- Finalización del estudio
- 2030-07 Estimado
- Primera publicación
- 16 jul 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026