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Orelabrutinib for Multiple Sclerosis
Study Summary
This trial is testing a new drug for patients with relapsing-remitting multiple sclerosis. The drug will be compared to a placebo to see if it is effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an immune system disorder that is not multiple sclerosis.You have a new health problem that showed up during the main part of the study.I have had cancer before, but it was only skin cancer that was treated successfully.You have attempted to harm yourself in the last 6 months, or have answered "yes" to questions 4 or 5 on the suicide assessment test.I have or had neurological conditions similar to MS.I have never had, nor do I currently have, a brain infection known as PML.My MS is getting worse.I have not had a heart attack or stroke in the last 6 months.I am between 18 and 55 years old.My disease has lasted more than 10 years and I have mild disability.I have had a major depression episode in the last 6 months.I have been diagnosed with Relapsing Remitting Multiple Sclerosis.My health hasn't changed in a way that would stop me from taking the study drug.I was permanently removed from the initial study due to severe side effects or abnormal conditions.My neurological condition has been stable for over a month.I have had at least one relapse in the past 2 years.Your EDSS score at Screening and Baseline (Day 1) should be between 0 and 5.5.
- Group 1: orelabrutinib(medium dose)
- Group 2: orelabrutinib (high dose)
- Group 3: placebo
- Group 4: orelabrutinib(low dose)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this a groundbreaking research effort?
"Presently, 14 active clinical trials for orelabrutinib are taking place in 59 cities and 4 countries. The earliest of these studies was sponsored by Beijing InnoCare Pharma Tech Co., Ltd. in 2019 with 81 participants completing its Phase 1 & 2 stages. Since then, a further 2689 drug tests have been concluded worldwide."
How many participants is this research endeavor accommodating?
"According to the sponsor, Beijing InnoCare Pharma Tech Co., Ltd., 160 participants will be required in order to run this trial. Premier Neurology, P.C. in Greer, South carolina and University of South Florida in Tampa, Florida are two possible locations where interested individuals can join the study if they meet all inclusion criteria."
Are there multiple locations within the U.S. conducting this experiment?
"Five sites are running the trial, with locations spanning from Greer to Tampa and Lincoln. To ensure minimal disruption due to travelling demands, participants should select the closest site available when signing up."
Are there any potential hazards of utilizing orelabrutinib therapeutically?
"The safety of orelabrutinib was assessed as a 2, given the Phase 2 trial status and the limited data regarding its efficacy."
Are candidates aged under 80 able to partake in this medical study?
"The parameters of this clinical trial necessitate that participants are aged between 18 and 55. Additionally, there are 43 studies available for minors while 404 trials are open to people above the age of 65."
What other research has been completed on the efficacy of orelabrutinib?
"Orelabrutinib was initially explored at Mayo Clinic in 2019, with 2689 trials completed. Currently, 14 studies are ongoing primarily located within Greer, South carolina."
Is my profile compatible with the criteria for participating in this clinical trial?
"This medical trial is recruiting 160 individuals living with multiple sclerosis who are aged between 18 and 55. To be eligible, applicants must have experienced a relapse in the last two years prior to screening, achieved an Expanded Disability Status Scale (EDSS) level of 0-5.5 at both Screening and Baseline (Day 1), been neurologically stable for 30 days before these points, women of childbearing age must use effective contraception, and patients already partaking in the Core Part that will benefit from continued treatment per their doctor's assessment can join if they have completed their end of treatment visit (OLE Part only)."
Are there any vacancies remaining in this investigation?
"Affirmative. As per the information on clinicaltrials.gov, this study is currently seeking participants and was first posted on March 1st 2021. There have been recent edits to the trial as of May 17th 2022; 160 volunteers are being recruited from 5 different sites."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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