A study to evaluate the efficacy and safety of remibrutinib in secondary progressive multiple sclerosis
Scientific Title of Study
A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis
Trial Acronym
REMASTER
Secondary IDs if Any
Secondary ID
Identifier
2025-521546-23
EudraCT
CLOU064P12301_Protocol Version 0.0_dated 26 Jun 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Murugananthan K
Designation
SSO Country Head
Affiliation
Novartis Healthcare Private Limited
Address
Novartis Healthcare Private Limited, 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India
Mumbai MAHARASHTRA 400051 India
Phone
02250243544
Fax
Email
murugananthan.k@novartis.com
Details of Contact Person Scientific Query
Name
Murugananthan K
Designation
SSO Country Head
Affiliation
Novartis Healthcare Private Limited
Address
Novartis Healthcare Private Limited, 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India
Mumbai MAHARASHTRA 400051 India
Phone
02250243544
Fax
Email
murugananthan.k@novartis.com
Details of Contact Person Public Query
Name
Murugananthan K
Designation
SSO Country Head
Affiliation
Novartis Healthcare Private Limited
Address
Novartis Healthcare Private Limited, 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India
7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Romania Argentina Australia Austria Belgium Brazil Bulgaria Canada China Colombia Czech Republic Denmark France Germany Greece Hungary India Israel Italy Mexico Netherlands Poland Portugal Slovakia South Africa Spain Switzerland United Kingdom United States of America
Sites of Study
No of Sites = 10
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ayush Agarwal
All India Institute of Medical Sciences (AIIMS)
Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi - 110029, India New Delhi DELHI
8193900444
dr.agarwal.ayush@gmail.com
Dr Ajith Sivadasan
Christian Medical College
Department of Neurological Sciences, Christian Medical College, Vellore, Ranipet Campus, Kilminnal Village, Tamil Nadu - 632517, India Vellore TAMIL NADU
9894197059
ajiths@cmcvellore.ac.in
Dr Surjyaprakash Choudhury
Institute of Medical Sciences & SUM Hospital
Department of Neurology, Institute of Medical Sciences & SUM Hospital, K-8, Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha - 751003, India Khordha ORISSA
9556062436
drsurjyaprakash@gmail.com
Dr Shankara Nellikunja
Mangala Hospital and Mangala Kidney Foundation
Mangala Hospital and Mangala Kidney Foundation, Vajra Hills, Kadri Road, Mangalore - 575003, Karnataka, India Dakshina Kannada KARNATAKA
9845080925
dr.shankaramnc@gmail.com
Dr Praveen Gupta
Marengo Asia Hospitals
Marengo Asia Hospitals, Golf Course Ext Rd, Sushant Lok II, Sector 56, Gurugram, Ghata, Haryana - 122011, India Gurgaon HARYANA
9891907903
dr.Praveen.gupta@marengoasia.com
Dr Sireesha Yareeda
Nizam’s Institute of Medical Sciences
Nizam’s Institute of Medical Sciences, Millennium block, Ground Floor, Department of Neurology, Panjagutta, Hyderabad, Telangana - 500082, India Hyderabad TELANGANA
9966406827
mailforsiree@gmail.com
Dr Dheeraj Khurana
Postgraduate Institute of Medical Education and Research (PGIMER)
Suite 18, Department of Neurology, Ground Floor, Block A, Nehru Hospital, PGIMER, Sector 12, Chandigarh - 160012, India Chandigarh CHANDIGARH
9815066990
dheraj.khurana@gmail.com
Dr Suresh Kumar
Renai Medicity
Department of Neurology, Renai Medicity, Post Box No. 2259, Palarivattom P.O., Kochi, Kerala - 682025, India Ernakulam KERALA
9447708161
rkvilla3@gmail.com
Dr Anshu Rohatgi
Sir Gangaram Hospital
Department of Neurology, Sir Gangaram Hospital, Sir Gangaram Hospital Marg, Rajindar Nagar, New Delhi - 110060, India New Delhi DELHI
9810159046
rohatgianshu@yahoo.com
Dr Sruthi Nair
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Medical College PO, Thiruvananthapuram - 695011, Kerala, India Thiruvananthapuram KERALA
• Signed informed consent must be obtained prior to any assessment performed.
• Male or female participants aged 18 to 65 years (inclusive) at Screening.
• Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) 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.
ExclusionCriteria
Details
• 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 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), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate less than 1 percent 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS
Time to 6-month confirmed disability progression
(6mCDP)
Secondary Outcome
Outcome
TimePoints
To assess whether remibrutinib is superior to placebo in:
- Delaying disability progression based on EDSS
- Other clinical and MRI measures
- Time to 3-month confirmed disability progression (3mCDP) on EDSS
- Time to 6-month confirmed disability improvement (6mCDI) on EDSS
- Time to 3-month worsening by at least 20 percent in Timed 25-Foot Walk (T25FW)
- Time to 3-month worsening by at least 20 percent in 9-Hole Peg Test (9-HPT)
- Annualized rate of new or enlarging T2 lesions
- Percentage of participants with annualized rate of brain atrophy greater than 0.45 percent
- Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT)
To assess the safety and tolerability of remibrutinib
Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS) from Baseline till End of Study
Target Sample Size
Total Sample Size="1275" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized in a ratio of 2:1 to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment. The purpose of this trial is
to learn about the effects of LOU064, also called remibrutinib, compared
to placebo in people with secondary
progressive multiple sclerosis.