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RecruitingPhase 3

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study consists of the following periods: * Screening Period: Up to 4 weeks. * Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well orelabrutinib works and how safe it is compared with a placebo, a pill with no active medicine. It is for adults with non-active secondary progressive multiple sclerosis (MS), whose disability has worsened without recent flare-ups. Treatment is planned for about 24 to 60 months, with a minimum of 12 months.

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 60 years old when you sign the consent form.
  • You previously had relapsing-remitting MS, a form with flare-ups followed by periods of recovery.
  • You now have secondary progressive MS, a form in which disability worsens over time.
  • Your medical records show worsening disability without a flare-up in the past 24 months. The study doctor and sponsor's medical team must agree on this evidence.
  • You have had no MS flare-ups for at least 24 months.

Who can't join

  • You have primary progressive MS, which worsens from the start, or another nerve or brain disorder that may look like MS.
  • You have an immune system disorder other than MS, or another condition needing steroid treatment.
  • You have ever had progressive multifocal leukoencephalopathy, a serious brain infection, or you now have a serious active viral, bacterial, or fungal infection.
  • You have a history of another serious active medical condition, have ever had cancer, or have important abnormal lab results at screening.
  • You have had suicidal behavior in the 6 months before screening, or alcohol or other drug abuse in the 12 months before screening.
  • You take blood thinners or medicines that keep blood cells called platelets from forming clots.
  • You took medicines that strongly or moderately change the activity of CYP3A, a protein that breaks down medicines, within 14 days.
  • You received a vaccine containing live or weakened virus in the month before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s). 5. Absence of clinical relapses for at least 24 months. Exclusion Criteria: 1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria 2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy. 3. History or current diagnosis of other neurological disorders that may mimic MS 4. History or current diagnosis of progressive multifocal leukoencephalopathy 5. Active, clinically significant viral, bacterial, or fungal infection 6. History of any other significant active medical condition 7. History of suicidal behavior within 6 months prior to Screening 8. Any prior history of malignancy 9. Patients on anticoagulation, or antiplatelet therapy 10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days 11. Clinically significant laboratory abnormalities at Screening. 12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening 13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Study sites (26)

AZ

CA

FL

IN

KS

MA

MI

MO

NM

NY

OH

OK

SC

TN

TX