A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis
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)
Sites / Locations
- Neurology Associates of Ormond Beach
- University of South Florida
- Consultants in Neurology LTD
- Neurology Associates, P.C.
- Premier Neurology, P.C.
- The First Affiliated Hospital of Anhui Medical University
- Peking Union Medical College Hospital
- Beijing Tiantan Hospital, Capital Medical University
- The First Affiliated Hospital of Chongqing Medical University
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
- Xiangya Hospital, Central South University
- The First Hospital of Jilin University
- Shengjing Hospital of China Medical University
- Huashan Hospital, Fudan University
- The 1st Affiliated Hospital of Shanxi Medical University
- The Second Affiliated Hospital of Air Force Military Medical University
- West China Hospital, Sichuan University
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
- Prywatna Praktyka Lekarska
- Resmedica NZOZ Kielce
- MCD Medical
- Neuromed
- Nzoz "Neuro-Kard"
- Wielospecjalistyczne Centrum Medyczne Ibismed
- CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology
- Medical Center of Dnipro State Medical University, Dnipro State Medical University
- SI USSRI of Medical and Social Problems of Disabilities of MOHU
- CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
- Institute of Neurology, Psychiatry and Narcology of NAMSU
- SI Institute of Neurology, Psychiatry and Narcology of NAMSU
- CIH Kharkiv City General Practice
- Medical Center of Limited Liability Company Medbud-Clinic
- CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
- CNE City Clinical Hospital #5 of Lviv
- CNE Odesa Regional Clinical Hospital of Odesa Regional Council
- Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center
- Medical Center of Limited Liability Company Medical Center Saliutem
- Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council
- CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1
- CNE Zaporizhzhia Regional Clinical Hospital of ZRC
- Medical Center of Limited Liability Company INET-09
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
placebo
orelabrutinib(low dose)
orelabrutinib(medium dose)
orelabrutinib (high dose)
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.
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.
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.
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.