What is the mechanism of action of this treatment?

Multiple Sclerosis (MS) treatments often target the immune system to reduce inflammation and prevent further damage to the nervous system. Orelabrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, works by blocking BTK, which plays a crucial role in the activation of B cells and macrophages, thereby reducing inflammation and immune response. Other common treatments include beta interferons, which modulate the immune system to reduce inflammation, and glatiramer acetate, which mimics myelin protein to divert the immune attack away from nerve fibers. These mechanisms are vital for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, ultimately improving quality of life.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include dimethyl fumarate, glatiramer acetate, and alemtuzumab. Dimethyl fumarate can cause gastrointestinal issues, flushing, and lymphopenia. Glatiramer acetate is associated with injection site reactions and, less commonly, systemic post-injection reactions. Alemtuzumab may lead to serious infections and autoimmune disorders, including immune thrombocytopenia. While specific side effects of Orelabrutinib are not detailed, similar Bruton's Tyrosine Kinase Inhibitors can cause infections, bleeding issues, and cytopenias.

What prior FDA approvals exist?

Ocrelizumab is an FDA-approved treatment for Multiple Sclerosis, specifically for both relapsing forms of MS and primary progressive MS. It is a monoclonal antibody that targets CD20-positive B cells, which are believed to play a role in the disease process. While Ocrelizumab is not a BTK inhibitor like Orelabrutinib, it represents a targeted B-cell therapy approach in MS treatment. Other FDA-approved treatments for MS include interferon beta-1a, interferon beta-1b, glatiramer acetate, and more recently, oral medications such as fingolimod, dimethyl fumarate, and teriflunomide.

What other types of research exist?

Promising novel alternatives to Orelabrutinib for Multiple Sclerosis patients include other BTK inhibitors such as Evobrutinib and Tolebrutinib, which are currently being evaluated in clinical trials. Additionally, therapies targeting B cells, like Ofatumumab, and S1P receptor modulators, such as Ozanimod and Ponesimod, are also showing potential in treating MS.

← Back to Search

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)

Must not have

Immunologic disorder other than MS

History or current diagnosis of other neurological disorders that may mimic MS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 weeks

Summary

This trial is testing Orelabrutinib, a medication for people with Relapsing-Remitting Multiple Sclerosis. It aims to reduce immune cell activity that causes attacks on the nervous system, potentially lowering the frequency and severity of relapses.

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.

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.

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

Select...

I am between 18 and 55 years old.

Select...

I have been diagnosed with Relapsing Remitting Multiple Sclerosis.

Select...

I have had at least one relapse in the past 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an immune system disorder that is not multiple sclerosis.

Select...

I have or had neurological conditions similar to MS.

Select...

I have never had, nor do I currently have, a brain infection known as PML.

Select...

My MS is getting worse.

Select...

I was permanently removed from the initial study due to severe side effects or abnormal conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The cumulative number of new GdE T1 MRI brain lesions

Secondary study objectives

ARR[efficacy]

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]

Other study objectives

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments often target the immune system to reduce inflammation and prevent further damage to the nervous system. Orelabrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, works by blocking BTK, which plays a crucial role in the activation of B cells and macrophages, thereby reducing inflammation and immune response. Other common treatments include beta interferons, which modulate the immune system to reduce inflammation, and glatiramer acetate, which mimics myelin protein to divert the immune attack away from nerve fibers. These mechanisms are vital for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, ultimately improving quality of life.

Mode of action and clinical studies with alemtuzumab.