A Study of Orelabrutinib in Patients With Primary 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 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Orelabrutinib
- Placebo
Treatment groups
705 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov