Multiple Sclerosis (MS) Primary Progressive study: Orelabrutinib
Official title A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT07067463
What this study is testing
What is Orelabrutinib?
This is an investigational oral medicine being studied as a potential treatment for primary progressive multiple sclerosis. It is designed to block a specific protein called BTK that helps control immune system activity in the brain and spinal cord.
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 find out whether orelabrutinib is effective and safe for treating primary progressive multiple sclerosis.
- Who it's for
- Adults who have primary progressive multiple sclerosis.
- What's involved
- Participants will take either orelabrutinib or a placebo pill in a double‑blind setup, with regular clinic visits and safety tests.
- Time commitment
- Treatment will continue for up to 30–60 months, with a minimum of 12 months, and requires periodic study visits.
- Phase 3: a large, late-stage study
- 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
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Pheonix, Arizona, United States
- Scottsdale, Arizona, United States
- West Hollywood, California, United States
- Bradenton, Florida, United States
- Maitland, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Kansas City, Kansas, United States
- Roeland Park, Kansas, United States
- St Louis, Missouri, United States
- Livingston, New Jersey, United States
- Raleigh, North Carolina, United States
- Columbus, Ohio, United States
- Greenville, South Carolina, United States
- Cordova, Tennessee, United States
- San Antonio, Texas, United States
- Sherman, Texas, United States
- Milwaukee, Wisconsin, United States
- Melbourne, Australia
- Pleven, Pleven, Bulgaria
+ 54 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Pheonix, Arizona, United States; Scottsdale, Arizona, United States; West Hollywood, California, United States; Bradenton, Florida, United States; Maitland, Florida, United States; Orlando, Florida, United States and 68 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.