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Research summary · AI summary · not yet reviewedHuman studyPhase 3Trial registry
Phase 3 Study of Orelabrutinib in Humans with Primary Progressive Multiple Sclerosis
A phase 3, randomized, double-blind study was conducted to evaluate orelabrutinib's efficacy and safety in approximately 705 patients with Primary Progressive Multiple Sclerosis (PPMS). The primary endpoint focused on the time until confirmed disability progression over at least 12 weeks, with a follow-up period of up to 120 weeks. Results have not yet been published.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
This study is important because it investigates a new treatment for PPMS, a form of multiple sclerosis with limited options. Understanding the efficacy and safety of orelabrutinib could impact future treatment strategies.
What this does not prove
Currently, there are no results or outcomes available from the study, which means we cannot assess its effectiveness or safety based on this evidence alone.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 705 · Estimated
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- PPMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (14)
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 PPMS.
study designThis 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.
subjectsThis 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.
speciesThis 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.
sample sizeThe study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally."
sample size basisThe study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally."
randomizedThis 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.
controlledThis 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.
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.",
interventionOrelabrutinib is a CNS-penetrable BTK inhibitor.
primary endpoint"measure": "Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP)",
follow up"timeFrame": "Up to approximately 120 weeks"
findingsThis 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.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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