Orelabrutinib in Human Subjects with Non-Active Secondary Progressive MS
A phase 3, randomized, double-blind study is ongoing to evaluate orelabrutinib versus a placebo in approximately 990 human subjects with non-active Secondary Progressive MS. Participants will receive treatment for 24 to 60 months, followed by a 4-week safety follow-up. Currently, the study is still recruiting, and no results are yet available.
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Why it matters
This study aims to assess whether orelabrutinib can delay disability progression in patients with MS, which would be significant for treatment options.
What this does not prove
No results have been published, and the study is still in progress, meaning planned endpoints are not yet outcomes.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (11)
randomizedAll eligible participants will be randomized at 2:1 ratio to accept orelabrutinib QD or placebo during the DB treatment period.
study phaseThis 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.
study design"detailedDescription": "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 naSPMS.
subjectsThe study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.\n\nThe study consists of the following periods:\n\n* Screening Period: Up to 4 weeks.\n* Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment.
controlledThe study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.\n\nThe study consists of the following periods:\n\n* Screening Period: Up to 4 weeks.\n* Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment.
interventionOrelabrutinib PO daily
comparatorPlacebo PO daily
primary endpoint"measure": "Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks",
follow upSafety Follow-Up Period: It will last 4 weeks.
findingsParticipants who are receiving IMP in DB or OL but do not consent to or are not eligible for enrollment in the LTS study, must return for a final safety follow-up visit 4 weeks later.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
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