Orelabrutinib for Multiple Sclerosis

Recruiting at 1 trial location

Overseen By Alexia Lu

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Must not be taking: Anticoagulants, Antiplatelets, CYP3A inhibitors, CYP3A inducers

Disqualifiers: RRMS, SPMS, Immunologic disorders, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30-60 months

705 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called orelabrutinib for individuals with Primary Progressive Multiple Sclerosis (PPMS). The researchers aim to determine if orelabrutinib can slow disability progression compared to a placebo (a substance with no active treatment). Participants will receive either the actual treatment or the placebo randomly and will be monitored for changes over time. This trial may suit those diagnosed with PPMS who have experienced worsening conditions in the past two years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulation, antiplatelet therapy, or certain other medications like strong/moderate CYP3A inhibitors or inducers within 14 days before the trial.

Is there any evidence suggesting that orelabrutinib is likely to be safe for humans?

Research shows that orelabrutinib, a drug tested for multiple sclerosis (MS), has a safety profile similar to other BTK inhibitors. Patients have generally tolerated orelabrutinib well. Studies comparing orelabrutinib to a placebo in people with different types of MS have enhanced understanding of its safety.

In one study, the dosage used effectively reduced lesions, which are damaged areas in the brain or spinal cord seen in MS. This suggests that the same dosage is likely safe for ongoing studies.

Overall, the safety of orelabrutinib is well-documented, and most patients manage the drug well. However, like any treatment, side effects or risks might occur, so participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Orelabrutinib is unique because it targets Bruton’s tyrosine kinase (BTK), which plays a crucial role in the immune system's B cells. Unlike traditional multiple sclerosis treatments like interferons or monoclonal antibodies, which may broadly suppress immune function, Orelabrutinib aims to modulate specific immune pathways, potentially leading to fewer side effects. Researchers are excited about Orelabrutinib because it offers a more targeted approach, which could improve patient outcomes and quality of life by reducing disease activity with potentially fewer risks.

What evidence suggests that orelabrutinib might be an effective treatment for multiple sclerosis?

Research has shown that orelabrutinib yields promising results for treating multiple sclerosis (MS), particularly in reducing brain lesions. In earlier studies, patients taking an 80 mg daily dose of orelabrutinib had over 90% fewer lesions compared to those on a placebo. MRI scans confirmed its effectiveness in patients with relapsing-remitting MS, another form of the disease. In this trial, participants will receive either orelabrutinib or a placebo at random. Although this study focuses on primary progressive MS, the significant reduction in lesions observed in past trials suggests that orelabrutinib could be effective here as well. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 60 with Primary Progressive Multiple Sclerosis (PPMS), as defined by the 2017 McDonald criteria. Participants must have shown disability progression in the last two years and have an EDSS score of 3.0 to 6.5.

Inclusion Criteria

I am between 18 and 60 years old.

I have been diagnosed with Primary Progressive MS.

My disability level is moderate to severe but I can still walk.

Exclusion Criteria

I do not have an immune disorder other than MS and I am not on steroids.

I have a neurological condition that could be confused with MS.

I had cancer before, but it hasn't come back in over 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orelabrutinib or placebo for approximately 30 to 60 months, with a minimum treatment duration of 12 months

30-60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orelabrutinib

Trial Overview

The study tests Orelabrutinib, a drug that can enter the central nervous system and may inhibit certain pathways involved in MS. It's compared against a placebo over a period of roughly one to five years, with patients randomly assigned in a ratio favoring Orelabrutinib.

How Is the Trial Designed?

Group I: Orelabrutinib Group Experimental Treatment 1 Intervention

Group II: Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Beijing InnoCare Pharma Tech Co., Ltd.

Lead Sponsor

Trials

48

Recruited

6,000+

Zenas BioPharma (USA), LLC

Lead Sponsor

Trials

8

Recruited

760+

Citations

1.

neurologylive.com

neurologylive.com/view/btk-inhibitor-orelabrutinib-shows-promising-efficacy-phase-2-study-relapsing-remitting-multiple-sclerosis

BTK Inhibitor Orelabrutinib Shows Promising Efficacy in ...

The 80 mg QD dosage, which showed the greatest efficacy in lesion reduction (92.3% at 24 weeks), will be used in phase 3 progressive MS studies.

2.

conferences.medicom-publishers.com

conferences.medicom-publishers.com/specialisation/neurology/actrims-2025/orelabrutinib-highly-effective-in-relapsing-remitting-ms-based-on-mri-results/

Orelabrutinib highly effective in relapsing-remitting MS, based ...

Based on MRI imaging data, orelabrutinib was highly effective in patients with relapsing-remitting MS in a double-blind, phase 2 trial.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07067463

NCT07067463 | A Study of Orelabrutinib in Patients With ...

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis.

4.

biospace.com

biospace.com/press-releases/data-of-innocares-orelabrutinib-for-the-treatment-of-ms-released-at-2025-actrims-forum

Data of InnoCare's Orelabrutinib for the Treatment of MS ...

The 80 mg QD group demonstrated the highest reductions of 90.4% at Week 12 compared to placebo and 92.3% at Week 24 compared to the placebo/50 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12052076/

Update on novel multiple sclerosis treatments: from dismal ...

This study is particularly important because it is the first drug to show a clear treatment effect on CDP and CDI in nrSPMS in a phase 3 trial.

6.

zenasbio.com

zenasbio.com/our-science/orelabrutinib/

Orelabrutinib

The safety and tolerability profile of orelabrutinib is consistent with other BTK inhibitors in development for MS and is well characterized across multiple ...

7.

innocarepharma.com

innocarepharma.com/uploads/2023-11-05/JPM.pdf

Orelabrutinib's Potential in Multiple Sclerosis

1 The Phase II trial evaluated the safety and efficacy of Orelabrutinib plus standard of care verse placebo plus standard of care (“SoC”) in ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04711148

NCT04711148 | A Phase 2 Study of Orelabrutinib in ...

This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.