This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
placebo
Orelabrutinib is a white, round, uncoated tablet
The cumulative number of new GdE T1 MRI brain lesions
To evaluate the efficacy of orelabrutinib on the cumulative number of new gadolinium-enhancing (GdE) T1 magnetic resonance (MRI) brain lesions versus placebo over 12 weeks of treatment.
Time frame: up to 120 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
To evaluate the safety and tolerability of orelabrutinib compared to placebo in the Core Part
Time frame: up to 120 weeks
ARR[efficacy]
Annualized relapse rate in the OLE Part
Time frame: up to 120 weeks
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Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
University of South Florida
Tampa, Florida, United States
Consultants in Neurology LTD
Northbrook, Illinois, United States
Neurology Associates, P.C.
Lincoln, Nebraska, United States
Premier Neurology, P.C.
Greer, South Carolina, United States
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
...and 32 more locations