Secondary Progressive Multiple Sclerosis study: Orelabrutinib
Official title A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT07299019
What this study is testing
What is Orelabrutinib?
an investigational oral medicine being studied as a potential treatment for secondary progressive multiple sclerosis is designed to inhibit Bruton’s tyrosine kinase (BTK) in the central nervous system, which may modulate immune activity
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if orelabrutinib is safe and works better than placebo in people with non‑active secondary progressive MS.
- Who it's for
- Adults who have secondary progressive multiple sclerosis that is not currently active.
- What's involved
- Participants will take oral orelabrutinib or a matching placebo and attend regular clinic visits for safety checks and tests.
- Time commitment
- Treatment lasts up to 24–60 months, with a minimum of 12 months, and requires periodic study visits.
- Phase 3: a large, late-stage study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening.
- Absence of clinical relapses for at least 24 months.
You likely can't join if
- The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
- Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
- History or current diagnosis of other neurological disorders that may mimic MS
- History or current diagnosis of progressive multifocal leukoencephalopathy
- Active, clinically significant viral, bacterial, or fungal infection
- History of any other significant active medical condition
See the full eligibility criteria
- 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening.
- Absence of clinical relapses for at least 24 months.
- The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
- Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
- History or current diagnosis of other neurological disorders that may mimic MS
- History or current diagnosis of progressive multifocal leukoencephalopathy
- Active, clinically significant viral, bacterial, or fungal infection
- History of any other significant active medical condition
- History of suicidal behavior within 6 months prior to Screening
- Any prior history of malignancy
- Patients on anticoagulation, or antiplatelet therapy
- Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
- Clinically significant laboratory abnormalities at Screening.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fullerton, California, United States
- Torrance, California, United States
- West Hollywood, California, United States
- Boca Raton, Florida, United States
- Bradenton, Florida, United States
- Clearwater, Florida, United States
- Maitland, Florida, United States
- Naples, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Roeland Park, Kansas, United States
- Worcester, Massachusetts, United States
- Rochester Hills, Michigan, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Columbus, Ohio, United States
+ 63 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Fullerton, California, United States; Torrance, California, United States; West Hollywood, California, United States; Boca Raton, Florida, United States and 77 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.