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RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Novartis Pharmaceuticals · NCT07225504

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1275
US sites recruiting
43
Study start
November 11, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Being studied: Remibrutinib (blinded); Placebo; Remibrutinib (Open label)

Conditions: Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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.

Exclusion Criteria

  • 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

Recruiting US locations

  • Alabama Neurology Associates PC

    Birmingham, AL 35209

    Site contact: Virginia Weinacker · +1 205 803 2210 · gweinacker@alaneuro.com

  • Xenoscience Inc

    Phoenix, AZ 85004

    Site contact: Derek Soto · +1 602 265 6500 · dsoto@xenoscience.com

  • Ctr for Neurology and Spine

    Phoenix, AZ 85018

    Site contact: Madison Turner · madison@centerforneurologyandspine.com

  • AZ Integrated Neuro and Spine

    Phoenix, AZ 85037

    Site contact: Nicole Hank · nhank@prcresearcheducation.com

  • Center for Neurosciences

    Tucson, AZ 85718

    Site contact: Lisa Alvarez · +1 520 320 2147 · lalvarez@neurotucson.com

  • Fullerton Neuro and Headache Ctr

    Fullerton, CA 92835

    Site contact: Alexandra Vasquez · +1 714 738 0800 · avasquez@fullertonneuro.net

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, CA 92663

    Site contact: Rachel Romansik · +1 949 288 5701 · Rachel.romansik@hoag.org

  • Regina Berkovich MD PhD Inc

    West Hollywood, CA 90048

    Site contact: Divya Venkataramu · +1 310 493 4715 · venkataramu.neuro@gmail.com

  • UC Health Neuroscience Ctr

    Aurora, CO 80045

    Site contact: Isabel Adkisson · isabel.adkisson@cuanschutz.edu

  • Georgetown University Hospital

    Washington D.C., DC 20007

    Site contact: Sree Nagaraj · +1 202 444 8830 · sn1031@georgetown.edu

  • Medstar Washington Hosp Ctr

    Washington D.C., DC 20010

    Site contact: Anu Bhooshan · +1 202 877 7000 · anu.r.bhooshan@medstar.net

  • Neurology of Central FL Res Ctr

    Altamonte Springs, FL 32714

    Site contact: Adiana Perez · +1 407 790 4990 · adiresearchcfl@gmail.com

  • UF Health Cancer Center

    Gainesville, FL 32610

    Site contact: Kyle Rizer · +1 352 733 2412 · kyle.rizer@neurology.ufl.edu

  • Homestead Assoc In Research Inc

    Homestead, FL 33033

    Site contact: Daydene Ordaz · 13052460873 · dordaz@associatesinresearch.com

  • Neurology Associates PA

    Maitland, FL 32751

    Site contact: Mary Grace Remedio · +1 407 647 5996 · grace.recruiter@naparesearch.com

  • Miami NS Ins Baptist Health S FL

    Miami, FL 33176

    Site contact: Sukie Hernandez · sukie.hernandez@baptisthealth.net

  • Aqualane Clinical Research

    Naples, FL 34105

    Site contact: Felicity Schlonsky · +1 239 434 0332 · felicity@aqualaneresearch.com

  • Orlando Health Clinical Trials

    Orlando, FL 32806

    Site contact: Charlene Carlo · +1 321 841 3686 · Charlene.carlo@orlandohealth.com

  • Comprehensive Neurology Clinic

    Orlando, FL 32825

    Site contact: Elliuz Leal · +1 407 913 9120 · elealcrc@gmail.com

  • Neurology Associates of Ormond Beach

    Ormond Beach, FL 32174

    Site contact: Heather Schutz · +1 386 676 6340 · hschutz@naobresearch.com

  • Axiom Brain Health

    Tampa, FL 33609

    Site contact: Analie Herbert · aherbert@axiombrainhealth.com

  • University Of South Florida

    Tampa, FL 33612

    Site contact: Eduardo Sucre · +1 813 974 6378 · eduardosucre@usf.edu

  • Joi Life Wellness Group LLC

    Smyrna, GA 30080

    Site contact: Semene Clement · 4043830845 · sclement@usf.edu

  • Hawaii Pacific Neuroscience LLC

    Honolulu, HI 96817

    Site contact: Gina McNarney · +1 808 261 4476 · gmcnarney@hawaiineuroscience.com

  • Northwestern Memorial Hospital

    Chicago, IL 60611

    Site contact: Caroline Gebczak · caroline.Gebczak@northwestern.edu

  • University of Kansas Hospital

    Kansas City, KS 66160

    Site contact: Sarah Razor · +1 913 945 5059 · sbellis2@kumc.edu

  • Mid Atlantic Epilepsy and Sleep Ctr

    Bethesda, MD 20817-1807

    Site contact: Salman Hashmi · hashmis@epilepsydc.com

  • Clinre Comprehensive Neurology

    Frederick, MD 21702

    Site contact: Saad Masroor Syed · +1 240 566 3130 · ssyed@clinre.com

  • Neuro Institute of New England P C

    Foxborough, MA 02035

    Site contact: Jillian Pellegrini · +1 781 551 5812 · jpellegrini@neurocenterne.com

  • Elliot Lewis MS Center

    Wellesley, MA 02481

    Site contact: Isabelle Messina · +1 781 591 8300 · isabellemessina@elliotlewisms.org

  • U Mass Memorial Medical Center

    Worchester, MA 01605

    Site contact: Nimmy Francis · +1 508 856 5073 · nimmy.rosefrancis@umassmed.edu

  • Michigan Institute of Neurological

    Farmington Hills, MI 48334

    Site contact: Emily Blazejewski · +1 248 553 0010 · eblazejewski@mindonline.com

  • University of New Mexico Hospital

    Albuquerque, NM 87106

    Site contact: Sophia Pearson · +1 505 272 4550 · SMPearson@salud.unm.edu

  • Atrium Health

    Charlotte, NC 28207

    Site contact: Catherine Tsoulos · +1 704 468 0101 · catherine.tsoulos@atriumhealth.org

  • Velocity Clinical Research

    Raleigh, NC 27607

    Site contact: Harsh Patel · +1 984 251 1336 · HPatel@velocityclinical.com

  • Cleveland Clinic Ohio

    Cleveland, OH 44195

    Site contact: Dawn Maniawski · maniawd@ccf.org

  • Premier Neurology

    Greenville, SC 29605

    Site contact: Jada Crawford · jada.c@premier-neuro.com

  • Neurology Clinic PC

    Cordova, TN 38018

    Site contact: Ye Liu · +1 901 866 9252 · yliu@neuroclinic.org

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, TN 37204

    Site contact: Jordon Winn · jordon.winn@vumc.org

  • Carum Research

    Dallas, TX 75231

    Site contact: Maya Manjane · +1 214 750 9977 · maya.manjane@carumresearch.com

  • Saturn Research Solution

    Plano, TX 75024

    Site contact: Maxine Fligg · mfligg@saturnclinical.com

  • University of Washington MS Clinic

    Seattle, WA 98133

    Site contact: Elisa McGee · +1 206 598 3344 · emcgee@uw.edu

  • Citta Clinical Research

    Spokane, WA 99202

    Site contact: Jill Ciccarello · jciccarello@cittaclinicalresearch.com

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
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A Study to Evaluate the Efficacy and Safety of Remibrutinib in… (NCT07225504) | Bored Studies