Phase 3 Study of Orelabrutinib in Human Patients with Secondary Progressive Multiple Sclerosis
A Phase 3 clinical trial is being conducted to assess the efficacy and safety of orelabrutinib, compared to a placebo, in approximately 990 patients with non-active secondary progressive multiple sclerosis (SPMS). Participants will be randomly assigned to orelabrutinib or placebo groups over a treatment period of 24 to 60 months, focusing on the time to confirmed disability progression.
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Why it matters
If successful, this study could provide insights into new treatment options for individuals suffering from SPMS, a condition that currently has limited therapeutic alternatives.
What this does not prove
The study is still in the recruitment phase, and results have not yet been published. Thus, there is no evidence of effectiveness or safety 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
- Not reported
- Research areas
- Other
Original sources
Supporting passages (13)
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.
findings"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.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
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.
subjects"officialTitle": "A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis"
sample sizeThe study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
randomizedA month is defined as a period of 28 days by convention.\n* Double-blinded (DB) Treatment: All eligible participants will be randomized at 2:1 ratio to accept orelabrutinib QD or placebo during the DB treatment period.
controlledA month is defined as a period of 28 days by convention.\n* Double-blinded (DB) Treatment: All eligible participants will be randomized at 2:1 ratio to accept orelabrutinib QD or placebo during the DB treatment period.
research categoriesOrelabrutinib is a CNS-penetrable BTK inhibitor.
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"
interventionOrelabrutinib is a CNS-penetrable BTK inhibitor.
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