Status:
ACTIVE_NOT_RECRUITING
A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.
Detailed 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 assig...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04711148
Start Date
March 1 2021
End Date
March 1 2026
Last Update
April 21 2023
Active Locations (42)
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1
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174
2
University of South Florida
Tampa, Florida, United States, 33612
3
Consultants in Neurology LTD
Northbrook, Illinois, United States, 60062
4
Neurology Associates, P.C.
Lincoln, Nebraska, United States, 68510