Multiple Sclerosis Clinical Trial
A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Are 18 to 55 years of age at the time of signing the informed consent.
Are diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).
Are neurologically stable for ≥ 30 days prior to both Screening and Baseline.
One or more documented relapses within the 2 years before Screening
Have an EDSS score of 0 to 5.5 at Screening and Baseline (Day 1)
Women of childbearing potential must use effective method of contraception
Signed and dated informed consent
Patient currently participating in the Core Part who has completed the end of treatment visit and will be benefit from continued treatment per investigator's assessment. (OLE Part only)
Exclusion Criteria:
Diagnosed with progressive MS.
Disease duration > 10 years in participants with an EDSS ≤ 2.0 at Screening and Baseline (Day 1).
Immunologic disorder other than MS.
History or current diagnosis of other neurological disorders that may mimic MS.
History or current diagnosis of progressive multifocal leukoencephalopathy (PML).
History of myocardial infarction or cerebrovascular event within 6 months prior to Screening,
A history of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.
An episode of major depression within the last 6 months prior to Screening (clinically stable minor depression is not exclusionary).
History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin
Breastfeeding/lactating or pregnant women
Participants are excluded from participation in the study if taken prohibited medications/treatments.
Participation in any investigational drug study within 6 months or 5 half-lives of the investigational drug, whichever is longest, prior to Screening.
Permanent discontinuation from the Core Part due to AE/ SAE or abnormal abnormalities or conditions leading to permanent study drug discontinuation. (OLE Part only)
Patient who has new abnormality appeared in the Core Part. (OLE Part only)
Any significant change in the subject's medical history that would preclude administration of the study drug. (OLE Part only)
Clinically significant laboratory abnormalities from the most recently available test in the Core Part that would preclude administration of the study drug. (OLE Part only)
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There are 37 Locations for this study
Ormond Beach Florida, 32174, United States
Tampa Florida, 33612, United States
Northbrook Illinois, 60062, United States
Lincoln Nebraska, 68510, United States
Greer South Carolina, 29650, United States
Hefei Anhui, 23002, China
Beijing Beijing, 10003, China
Beijing Beijing, 10007, China
Yuzhong Chongqing, 40001, China
Wuhan Hubei, 43006, China
Changsha Hunan, 41000, China
Changchun Jilin, 13002, China
Shengyang Liaoning, 11000, China
Shanghai Shanghai, 20004, China
Taiyuan Shanxi, , China
Xi'an Shanxi, 71003, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31000, China
Katowice , 40-12, Poland
Katowice , 40-57, Poland
Kielce , 25-72, Poland
Krakow , 31-63, Poland
Lublin , 20-95, Poland
Poznan , 61-85, Poland
Zabrze , 41-80, Poland
Dnipro , 49005, Ukraine
Dnipro , 49027, Ukraine
Dnipro , 49027, Ukraine
Ivano-Frankivsk , 76008, Ukraine
Kharkiv , 61068, Ukraine
Kharkiv , 61068, Ukraine
Kharkiv , 61172, Ukraine
Kyiv , 3110, Ukraine
Lviv , 79010, Ukraine
Lviv , 79013, Ukraine
Odesa , 65025, Ukraine
Vinnytsia , 21009, Ukraine
Vinnytsia , 21050, Ukraine
Zaporizhzhia , 69035, Ukraine
Zaporizhzhia , 69600, Ukraine
Zaporizhzhia , 69600, Ukraine
Zaporizhzhya , 69035, Ukraine
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