Phase 3 Study of Orelabrutinib in Animal/Cell Models
A phase 3, randomized, double-blind study is designed to assess the effect of the drug orelabrutinib on disability progression in patients with Primary Progressive Multiple Sclerosis (PPMS) versus a placebo. The study's primary endpoint is the time to onset of confirmed disability progression over 12 weeks, with a follow-up of approximately 120 weeks.
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Why it matters
This study is significant as it attempts to determine the drug's efficacy and safety for PPMS, a type of MS with limited treatment options.
What this does not prove
No results from the study are posted, and the planned enrolment and endpoints are not outcomes or findings, limiting the understanding of the study's impact.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- PPMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
Supporting passages (12)
regulatory approval details"isFdaRegulatedDrug": true
randomized"allocation": "RANDOMIZED"
controlled"type": "PLACEBO_COMPARATOR"
regulatory approval"isFdaRegulatedDrug": true
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.
relevant ms types"Multiple Sclerosis (MS) Primary Progressive"
intervention"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.",
comparator"Drug: Placebo"
primary endpoint"measure": "Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-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.
limitationsPlanned enrolment and endpoints are not findings.
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