A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZenas BioPharma (USA), LLC
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
History or current diagnosis of other neurological disorders that may mimic MS
History or current diagnosis of progressive multifocal leukoencephalopathy
Trial design
Treatments tested in this trial
- Orelabrutinib
- Placebo
Treatment groups
990 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov