Status and phase
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About
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.
Full description
The study contains 2 parts: Core Part and an Open-label Extension (OLE) Part.
The Core Part is a randomized, double-blind, placebo-controlled, phase 2 study. Patients with RRMS will be randomly assigned to 1 of 4 treatment groups. placebo, orelabrutinib (low dose), orelabrutinib (medium dose) and orelabrutinib (high dose) at a 1:1:1:1 ratio.
The OLE part is an open-label, single treatment arm study to enroll patients who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data.All patients will receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.
Enrollment
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Inclusion criteria
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Primary purpose
Allocation
Interventional model
Masking
160 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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