Orelabrutinib for Multiple Sclerosis

Not currently recruiting at 42 trial locations

Overseen By Olivia Yang

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Disqualifiers: Progressive MS, Immunologic disorder, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new drug, Orelabrutinib, can help people with Relapsing-Remitting Multiple Sclerosis (RRMS), a condition where the immune system mistakenly attacks the protective covering of nerves, causing symptoms to come and go. Participants will receive either different doses of Orelabrutinib or a placebo to compare effects. The goal is to determine if this drug can reduce relapses and improve quality of life. Candidates may qualify if they've experienced RRMS with one or more relapses in the past two years and are currently stable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes participants who have taken prohibited medications or treatments. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that orelabrutinib, a BTK inhibitor, is generally well-tolerated by patients. Studies have found its safety profile to be similar to other BTK inhibitors tested for multiple sclerosis (MS). In earlier studies, most patients did not experience serious side effects from orelabrutinib. Reported side effects were mostly mild to moderate, such as headaches or mild skin reactions, which are common with many treatments.

While some side effects might occur, they are usually not severe. These findings suggest that orelabrutinib could be a safe option for treating relapsing-remitting multiple sclerosis, based on evidence from various studies. However, as with any treatment, individual experiences can differ, so discussing potential risks with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about orelabrutinib for multiple sclerosis because it targets a specific enzyme called Bruton's tyrosine kinase (BTK), which plays a crucial role in the immune system. Unlike typical treatments like interferons or glatiramer acetate, which modulate immune responses broadly, orelabrutinib offers a more targeted approach, potentially reducing inflammation with fewer side effects. This precision in targeting BTK could lead to improved efficacy in managing multiple sclerosis symptoms and slowing disease progression, making it a promising new option for patients.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Studies have shown that orelabrutinib effectively treats relapsing-remitting multiple sclerosis (MS). MRI scans reveal a significant reduction in brain lesions, with up to a 92.3% decrease at 24 weeks compared to a placebo. This trial will evaluate different doses of orelabrutinib—high, medium, and low—against a placebo. Past research identified the 80 mg dose as the most effective, making it a strong candidate for future studies. Overall, the evidence suggests that orelabrutinib could be a promising treatment for individuals with relapsing-remitting MS. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Relapsing Remitting Multiple Sclerosis.

My neurological condition has been stable for over a month.

Women of childbearing potential must use effective method of contraception

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Part Treatment

Participants receive either placebo or varying doses of orelabrutinib for 24 weeks

24 weeks

Open-label Extension

Participants who completed the Core Part continue treatment with orelabrutinib to collect long-term safety and efficacy data

up to 96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orelabrutinib
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: orelabrutinib(medium dose) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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: placebo Placebo Group 2 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.

Who Is Running the Clinical Trial?

Beijing InnoCare Pharma Tech Co., Ltd.

Lead Sponsor

Trials

48

Recruited

6,000+

Published Research Related to This Trial

In a 16-week study involving 130 participants with relapsing multiple sclerosis, tolebrutinib demonstrated a dose-dependent reduction in new active brain lesions, with the highest efficacy observed at the 60 mg dose.

Tolebrutinib was well tolerated, with only one serious adverse event reported and no treatment-related deaths, suggesting it is a safe option for reducing inflammation in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial. Reich, DS., Arnold, DL., Vermersch, P., et al.[2023]

Evobrutinib, a Bruton's tyrosine kinase inhibitor, was generally well tolerated across multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus trials, with similar rates of treatment-emergent adverse events (TEAEs) compared to placebo (66.2% vs 62.4%).

The analysis included data from 1083 patients across various trials, revealing that serious infections and liver enzyme elevations were comparable between evobrutinib and placebo, indicating a favorable safety profile for this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis. Montalban, X., Wallace, D., Genovese, MC., et al.[2023]

In a study of 128 multiple sclerosis patients, ocrelizumab was found to be well tolerated, with most side effects being mild and decreasing over time, indicating good short-term safety in a real-world setting.

The treatment also showed efficiency in stabilizing the disease, with no severe side effects reported, suggesting that ocrelizumab is a viable option for managing multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world application of ocrelizumab in multiple sclerosis: Single-center experience of 128 patients. Prockl, V., Nickel, FT., Utz, KS., et al.[2021]

In a study of 228 multiple sclerosis patients treated with ocrelizumab, 91.2% of those with relapsing forms of MS achieved no evidence of disease activity (NEDA) after one year, indicating strong effectiveness in managing the disease.

The treatment was generally well-tolerated, with the most common side effects being infusion-related reactions and infections, particularly urinary tract infections, suggesting a favorable safety profile in a real-world clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population. Fernandez-Diaz, E., Perez-Vicente, JA., Villaverde-Gonzalez, R., et al.[2021]

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. businesswire.com businesswire.com/news/home/20250226590199/en/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. innocarepharma.com innocarepharma.com/en/news/activity/en020240913-Orelabrutinib-Data-Presented-at-ESMO-2024

688428) orelabrutinib were presented at the European ... At a median follow-up of 12.7 months, 93.3% patients achieved an HR. Among the different orelabrutinib-based regimens, HR was achieved in 100% ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S3050623925000574

Safety and efficacy of Bruton's tyrosine kinase inhibitors in ... This systematic review and network meta-analysis evaluated the safety and efficacy of Bruton's tyrosine kinase (BTK) inhibitors in patients with ...

7. 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 ...

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.