A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Официальное название

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

Обзор

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.

Вмешательства

• Препарат Orelabrutinib
  Orally
• Препарат Placebo
  Orally

Первичные конечные точки

• Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP) [Срок оценки: Up to approximately 120 weeks]

Вторичные конечные точки (12)

• Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP) [Срок оценки: Up to approximately 120 weeks]
• Time to onset of confirmed disability progression (CDP) , confirmed over at least 24 weeks (24-week CDP) [Срок оценки: Up to approximately 120 weeks]
• MRI T2 lesion [Срок оценки: Up to approximately 120 weeks]
• 12-week CDP [Срок оценки: Up to approximately 120 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) [Срок оценки: Up to approximately 120 weeks]
• 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) [Срок оценки: Up to approximately 120 weeks]
• 24-week cCDI [Срок оценки: Up to approximately 120 weeks]
• 24-week CDI-9HPT [Срок оценки: Up to approximately 120 weeks]
• 24-week CDI [Срок оценки: Up to approximately 120 weeks]
• 24-week CDI-T25FWT [Срок оценки: Up to approximately 120 weeks]
• SDMT [Срок оценки: Up to approximately 120 weeks]
• AEs [Срок оценки: Up to approximately 120 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Arizona Neuroscience Research, LLC — Pheonix
• Perseverance Research Center — Scottsdale
• Regina Berkovich MD, PhD Inc. — West Hollywood
• Nova Clinical Research, LLC — Bradenton
• Neurology Associates, PA — Maitland
• KC Research Center, PA Neurology Research Department — Roeland Park
• Washington University School of Medicine — St Louis
• Cooperman Barnabas Medical Center — Livingston
• … и ещё 6 центров

Польша · 13 центров

• ClinHouse Centrum Medyczne — Zabrze
• NZOZ Novo Med — Katowice
• Twoja Przychodnia PCM — Poznan
• Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy — Poznan
• Copernicus Podmiot Leczniczy Szpital im. M. Kopernika — Gdansk
• Galen Clinic — Lublin
• NZOZ Neuromed M. i M. Nastaj Sp.P — Lublin
• Malva Trials — Lublin
• … и ещё 5 центров

Болгария · 3 центра

• Medical Center Nevrocentrum — Plovdiv
• Diagnostic and Consultative Center Convex — Sofia
• Avis Medica Hospital Pleven — Pleven

Грузия · 3 центра

• MD Georgia Staff Physician MediClub Georgia — Tbilisi
• NNLE Jo Ann University Hospital — Tbilisi
• Raymann, LLC — Tbilisi

Сербия · 3 центра

• University Clinical Centre of Serbia — Belgrade
• Clinical Centre Kragujevac, Neurology clinic — Kragujevac
• University Clinical Centre of Kragujevac — Kragujevac

Испания · 3 центра

• Hospital Alvaro Cunqueiro — Vigo
• Hospital Vithas Nisa Sevilla — Castilleja de la Cuesta
• Complejo Hospitalario Universitario A Coruna — A Coruña

Хорватия · 1 центр

• Klinicki Bolnicki Centar Zagreb-Rebro — Zagreb

Чехия · 1 центр

• NEUROHK, s.r.o. — Choceň

Эстония · 1 центр

• Astra Clinic (Clinic4U) — Tallinn

Германия · 1 центр

• Neuro Centrum Science Gmbh Albert-Schwitzer — Erbach im Odenwald

Италия · 1 центр

• IRCCS Istituto Neurologico Mediterraneo Neuromed — Pozzilli

Нидерланды · 1 центр

• Zuyderland Medisch Centrum - Sittard-Geleen — Sittard

Румыния · 1 центр

• Spital Clinic CF Constanta — Constanța

Идентификаторы

NCT: NCT07067463 · ZB020-03-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗