A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT04711148
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2021-03-01
2026-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
The Core Part：Participants receive placebo
The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.
placebo
placebo
orelabrutinib
Orelabrutinib is a white, round, uncoated tablet
orelabrutinib(low dose)
The Core Part：Participants receive low dose orelabrutinib
The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.
orelabrutinib
Orelabrutinib is a white, round, uncoated tablet
orelabrutinib(medium dose)
The Core Part ：Participants receive medium dose orelabrutinib
The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.
orelabrutinib
Orelabrutinib is a white, round, uncoated tablet
orelabrutinib (high dose)
The Core Part：Participants receive high dose orelabrutinib
The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.
orelabrutinib
Orelabrutinib is a white, round, uncoated tablet
Interventions
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placebo
placebo
orelabrutinib
Orelabrutinib is a white, round, uncoated tablet
Eligibility Criteria
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Inclusion Criteria
2. Are diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).
3. Are neurologically stable for ≥ 30 days prior to both Screening and Baseline.
4. One or more documented relapses within the 2 years before Screening
5. Have an EDSS score of 0 to 5.5 at Screening and Baseline (Day 1)
6. Women of childbearing potential must use effective method of contraception
7. Signed and dated informed consent
8. 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
2. Disease duration \> 10 years in participants with an EDSS ≤ 2.0 at Screening and Baseline (Day 1).
3. Immunologic disorder other than MS.
4. History or current diagnosis of other neurological disorders that may mimic MS.
5. History or current diagnosis of progressive multifocal leukoencephalopathy (PML).
6. History of myocardial infarction or cerebrovascular event within 6 months prior to Screening,
7. 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.
8. An episode of major depression within the last 6 months prior to Screening (clinically stable minor depression is not exclusionary).
9. History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin
10. Breastfeeding/lactating or pregnant women
11. Participants are excluded from participation in the study if taken prohibited medications/treatments.
12. Participation in any investigational drug study within 6 months or 5 half-lives of the investigational drug, whichever is longest, prior to Screening.
13. Permanent discontinuation from the Core Part due to AE/ SAE or abnormal abnormalities or conditions leading to permanent study drug discontinuation. (OLE Part only)
14. Patient who has new abnormality appeared in the Core Part. (OLE Part only)
15. Any significant change in the subject's medical history that would preclude administration of the study drug. (OLE Part only)
16. 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)
18 Years
55 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Xiangya Hospital, Central South University
Changsha, Hunan, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China
The 1st Affiliated Hospital of Shanxi Medical University
Taiyuan, Shan'xi, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Air Force Military Medical University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
Katowice, , Poland
Prywatna Praktyka Lekarska
Katowice, , Poland
Resmedica NZOZ Kielce
Kielce, , Poland
MCD Medical
Krakow, , Poland
Neuromed
Lublin, , Poland
Nzoz "Neuro-Kard"
Poznan, , Poland
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze, , Poland
CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology
Dnipro, , Ukraine
Medical Center of Dnipro State Medical University, Dnipro State Medical University
Dnipro, , Ukraine
SI USSRI of Medical and Social Problems of Disabilities of MOHU
Dnipro, , Ukraine
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, , Ukraine
Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, , Ukraine
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, , Ukraine
CIH Kharkiv City General Practice
Kharkiv, , Ukraine
Medical Center of Limited Liability Company Medbud-Clinic
Kyiv, , Ukraine
CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
Lviv, , Ukraine
CNE City Clinical Hospital #5 of Lviv
Lviv, , Ukraine
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
Odesa, , Ukraine
Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center
Vinnytsia, , Ukraine
Medical Center of Limited Liability Company Medical Center Saliutem
Vinnytsia, , Ukraine
Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council
Zaporizhzhia, , Ukraine
CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1
Zaporizhzhia, , Ukraine
CNE Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhia, , Ukraine
Medical Center of Limited Liability Company INET-09
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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ICP-CL-00112
Identifier Type: -
Identifier Source: org_study_id
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