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RecruitingPhase 3

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

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

Not stated in the study description — ask the study team about visits and procedures.

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 treatment with no active drug. It is for adults ages 18 to 60 with primary progressive multiple sclerosis (PPMS), a form of MS that gets worse over time. Treatment is planned for about 30 to 60 months, with at least 12 months of treatment.

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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 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.
  • You have PPMS diagnosed using the 2017 McDonald rules for diagnosing MS.
  • Your medical records show that your disability got worse during the 24 months before screening.
  • Your score on the Expanded Disability Status Scale (EDSS), which measures disability from MS, is 3.0 to 6.5 at screening.

Who can't join

  • You have relapsing-remitting MS, secondary progressive MS, or another brain or nerve disorder that may look like MS.
  • You have an immune system disorder other than MS, a condition needing steroid pills or injections, or a history of another serious active health condition.
  • You had suicidal behavior in the past 6 months, or alcohol or other drug abuse in the past 12 months.
  • You have a history of cancer with no return of the cancer within 5 years.
  • You take blood thinners or medicines that keep blood cells from forming clots. You also cannot have taken medicines that strongly or moderately change the activity of CYP3A, a protein that breaks down medicines, within 14 days.
  • Your screening lab tests show important health problems.
  • You are allergic to orelabrutinib or its ingredients, cannot tolerate it, or have a medical reason you cannot take it.
  • You received a vaccine containing a live or weakened live virus within 1 month before screening.

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

Official eligibility criteria

Inclusion Criteria: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening. Exclusion Criteria: * Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) * Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy. * History or current diagnosis of other neurological disorders that may mimic MS * History of any other significant active medical condition * History of suicidal behavior within 6 months prior to Screening * Any prior history of malignancy if no recurrence within 5 years * Patients on anticoagulation, or antiplatelet therapy will be excluded * Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days * Clinically significant laboratory abnormalities at Screening. * Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention * Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening * History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Study sites (19)

AZ

CA

FL

KS

MO

NC

NJ

OH

SC

TN

TX

WI