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Tests treatment safety and results for Secondary Progressive Multiple Sclerosis (SPMS)
Official title A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT07225504
What this study is testing
What is Remibrutinib (blinded)?
Remibrutinib (blinded) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for secondary progressive multiple sclerosis (spms).
Also referred to as LOU064.
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 purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
- 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 65
You may be able to join if
- Signed informed consent must be obtained prior to any assessment performed.
- Male or female participants aged 18-65 (inclusive) at Screening.
- Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical...
- Absence of documented clinical relapses in the 24 months before Screening and randomization.
- EDSS score of 3.0 to 6.0 (inclusive) at Screening.
You likely can't join if
- Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic...
- History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of...
- Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability...
- Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
- Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking...
- Significant bleeding risk or coagulation disorders, at Screening.
See the full eligibility criteria
- Signed informed consent must be obtained prior to any assessment performed.
- Male or female participants aged 18-65 (inclusive) at Screening.
- Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening
- Absence of documented clinical relapses in the 24 months before Screening and randomization.
- EDSS score of 3.0 to 6.0 (inclusive) at Screening.
- Documented evidence of disability progression in the 12 months before Screening.
- Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
- History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
- Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
- Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
- Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.
- Significant bleeding risk or coagulation disorders, at Screening.
- Use of exclusionary medication prior to Screening/randomization as listed in the protocol. Other protocol-defined inclusion/exclusion critria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fullerton, California, United States
- West Hollywood, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Altamonte Springs, Florida, United States
- Gainesville, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Ormond Beach, Florida, United States
- Tampa, Florida, United States
- Smyrna, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
+ 184 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 - 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fullerton, California, United States; West Hollywood, California, United States; Aurora, Colorado, United States and 198 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.