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Recruiting NCT07067463

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Phase III Interventional Multiple Sclerosis (MS) Primary Progressive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orelabrutinib, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS) Primary Progressive. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, Croatia, Czechia, Estonia +8
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Orelabrutinib
    Orally
  • Drug Placebo
    Orally

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 14 centers
  • 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
  • … and 6 more centers
Poland · 13 centers
  • 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
  • … and 5 more centers
Bulgaria · 3 centers
  • Medical Center Nevrocentrum — Plovdiv
  • Diagnostic and Consultative Center Convex — Sofia
  • Avis Medica Hospital Pleven — Pleven
Georgia · 3 centers
  • MD Georgia Staff Physician MediClub Georgia — Tbilisi
  • NNLE Jo Ann University Hospital — Tbilisi
  • Raymann, LLC — Tbilisi
Serbia · 3 centers
  • University Clinical Centre of Serbia — Belgrade
  • Clinical Centre Kragujevac, Neurology clinic — Kragujevac
  • University Clinical Centre of Kragujevac — Kragujevac
Spain · 3 centers
  • Hospital Alvaro Cunqueiro — Vigo
  • Hospital Vithas Nisa Sevilla — Castilleja de la Cuesta
  • Complejo Hospitalario Universitario A Coruna — A Coruña
Croatia · 1 center
  • Klinicki Bolnicki Centar Zagreb-Rebro — Zagreb
Czechia · 1 center
  • NEUROHK, s.r.o. — Choceň
Estonia · 1 center
  • Astra Clinic (Clinic4U) — Tallinn
Germany · 1 center
  • Neuro Centrum Science Gmbh Albert-Schwitzer — Erbach im Odenwald
Italy · 1 center
  • IRCCS Istituto Neurologico Mediterraneo Neuromed — Pozzilli
Netherlands · 1 center
  • Zuyderland Medisch Centrum - Sittard-Geleen — Sittard
Romania · 1 center
  • Spital Clinic CF Constanta — Constanța

Identifiers

NCT: NCT07067463 · ZB020-03-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗