Phase 3 Study of Orelabrutinib in Human Subjects with Non-active Secondary Progressive Multiple Sclerosis
A Phase 3 study was conducted to evaluate the efficacy and safety of orelabrutinib compared to placebo in 990 patients with non-active secondary progressive multiple sclerosis. The primary endpoint was the time to onset of confirmed disability progression over at least 24 weeks, but no results have been posted yet.
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Why it matters
This research aims to provide insights into a potential new treatment for a specific type of multiple sclerosis, focusing on whether orelabrutinib might effectively prevent disability progression in affected individuals.
What this does not prove
No results are available, and planned enrollment and endpoints do not constitute findings. We cannot assess the efficacy or safety of orelabrutinib at this time.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 990 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- SPMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Other
Original sources
Supporting passages (16)
controlled"primaryPurpose": "TREATMENT",
study phase"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.
study designThe 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.
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.
sample size"enrollmentInfo": { "count": 990, "type": "ESTIMATED" }
randomized"allocation": "RANDOMIZED"
peer reviewedNo results are posted.
regulatory approval"isFdaRegulatedDrug": true
research categories"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.
relevant ms types"officialTitle": "A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis"
intervention"briefSummary": "Orelabrutinib is a CNS-penetrable BTK inhibitor.
comparator"Placebo PO daily"
primary endpoint"measure": "Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks",
follow upThe study will be unblinded when all participants in the DB period have reached a minimum treatment duration of 12 months at the time of primary analysis timing cutoff.\n* Open-label (OL) Treatment: Participants with 24-week CDP as assessed by EDSS are eligible for 2-year open-label orelabrutinib treatment.\n* Safety Follow-Up Period: It will last 4 weeks.
findingsNo results are posted.
limitationsPlanned enrolment and endpoints are not findings.
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