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Bruton's Tyrosine Kinase (BTK) Inhibitor

Orelabrutinib for Multiple Sclerosis

Phase 2
Waitlist Available
Research Sponsored by Beijing InnoCare Pharma Tech Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are 18 to 55 years of age at the time of signing the informed consent
Are diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 weeks
Awards & highlights

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.

Who is the study for?
This trial is for adults aged 18-55 with Relapsing Remitting Multiple Sclerosis (RRMS) who've had at least one relapse in the past two years and have an EDSS score of 0 to 5.5. Women must use contraception, and participants should be neurologically stable for over a month before starting.Check my eligibility
What is being tested?
The study tests Orelabrutinib against a placebo in a double-blind setup, meaning neither the patients nor the researchers know who's receiving the actual drug or placebo during the trial phase.See study design
What are the potential side effects?
While specific side effects are not listed here, typical clinical trials may monitor for any new symptoms like headaches, nausea, fatigue or allergic reactions that could arise from taking Orelabrutinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I have been diagnosed with Relapsing Remitting Multiple Sclerosis.
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My neurological condition has been stable for over a month.
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I have had at least one relapse in the past 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The cumulative number of new GdE T1 MRI brain lesions
Secondary outcome measures
ARR[efficacy]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
Other outcome measures
Peak concentration (Cmax)

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: orelabrutinib(medium dose)Experimental Treatment1 Intervention
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.
Group II: orelabrutinib(low dose)Experimental Treatment1 Intervention
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.
Group III: orelabrutinib (high dose)Experimental Treatment1 Intervention
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.
Group IV: placeboPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Beijing InnoCare Pharma Tech Co., Ltd.Lead Sponsor
41 Previous Clinical Trials
4,303 Total Patients Enrolled

Media Library

Orelabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04711148 — Phase 2
Multiple Sclerosis Research Study Groups: orelabrutinib(medium dose), orelabrutinib (high dose), placebo, orelabrutinib(low dose)
Multiple Sclerosis Clinical Trial 2023: Orelabrutinib Highlights & Side Effects. Trial Name: NCT04711148 — Phase 2
Orelabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04711148 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Premier Neurology, P.C.
What portion of applicants met pre-screening criteria?
Met criteria
~60 spots leftby Feb 2026