Find Multiple Sclerosis (MS) Clinical Trials Near You
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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 non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 18 to 60 years of age, inclusive, at the time of signing the informed consent.
• Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
• Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
• Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).
• Absence of clinical relapses for at least 24 months.
Locations
United States
Arizona
Arizona Neuroscience Research, LLC
RECRUITING
Phoenix
Perseverance Research Center, LLC (PRC)
RECRUITING
Scottsdale
California
Fullerton Neurology and Headache Center
RECRUITING
Fullerton
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))
RECRUITING
Torrance
Regina Berkovich MD, PhD Inc
RECRUITING
West Hollywood
Florida
SFM Clinical Research, LLC
RECRUITING
Boca Raton
Nova Clinical Research, LLC
RECRUITING
Bradenton
MS and Neuromuscular Center of Excellence
RECRUITING
Clearwater
Neurology Associates
RECRUITING
Maitland
Aqualane Clinical Research
RECRUITING
Naples
Indiana
Josephson Wallack Munshower Neurology, Pc Suite 225
RECRUITING
Indianapolis
Kansas
KC Research Center, PA Neurology Research Dept
RECRUITING
Roeland Park
Massachusetts
Boston Clinical Trials
WITHDRAWN
Boston
Michigan
Profound Research LLC at Oakland Neurology Center
RECRUITING
Rochester Hills
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Ohio
The Boster Center for Multiple Sclerosis
RECRUITING
Columbus
Oklahoma
OMRF Multiple Sclerosis Center of Excellence
RECRUITING
Oklahoma City
South Carolina
Premier Neurology
RECRUITING
Greenville
Tennessee
Neurology Clinic, P.C.
RECRUITING
Cordova
Texas
Lone Star Neurology
RECRUITING
San Antonio
Texas Institute for Neurological Disorders - Sherman
RECRUITING
Sherman
Other Locations
Croatia
Klinicki Bolnicki Centar Zagreb-Rebro
RECRUITING
Zagreb
Estonia
Astra clinic (Clinic4U)
RECRUITING
Tallinn
Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
RECRUITING
Pozzilli
Lithuania
Hospital of Lithuanian University of Health Sciences
RECRUITING
Kaunas
Poland
Centrum Medyczne INTERCOR Sp. z o.o.
RECRUITING
Bydgoszcz
MA-LEK Clinical Sp. z o.o.
RECRUITING
Katowice
NZOZ Novo Med
RECRUITING
Katowice
PRO SALUS Sp. z o.o. sp.k.
RECRUITING
Lodz
Galen Clinic
RECRUITING
Lublin
Malva Trials
RECRUITING
Lublin
Twoja Przychodnia Centrum Medyczne Nowa Sól
RECRUITING
Nowa Sól
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy