CLOU064P12301: remibrutinib in patients with secondary progressive multiple sclerosis.
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis.
IRAS ID
1012443
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2025-521546-23
Research summary
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 (SPMS). LOU064 is a drug designed to bind to the protein called BTK which is found in certain immune cells involved in causing inflammation and damage to the brain and spinal cord in MS. By blocking BTK protein activity, LOU064 may help to slow down the worsening of MS symptoms. Approximately 1275 are expected to join this trial. Participants’ ages can range from 18 to 65 years.
People can take part if they:
• have SPMS
• did not have any MS relapse within 2 years before joining the trial
• had worsening of their MS symptoms and/or of their physical abilities in the last year before joining this trial
• do not have other brain diseases, for example stroke, that may have symptoms similar to MS
This trial will have 2 parts: Part 1 (Core Part) and 2 (Extension Part). All enrolled participants will enter Part 1 of the trial.
Part 1, researchers use a computer program to randomly assign participants into 1 of the 2 groups. Participants are 2 times more likely to be placed into Group 1 than Group 2.
Group 1: Participants will take LOU064 as a tablet by mouth
Group 2: Participants will take placebo as a tablet by mouth
None of the participants, trial doctors, or trial staff will know which treatment the participants will receive in Part 1.
Researchers will check participants' MS and general health status on a regular basis.
Part 2; Participants who will continue in Part 2 will take LOU064 as a tablet by mouth, for a maximum of 3 years.
Participants, trial doctors, or trial staff will know which treatment the participants will receive in Part 2.
Researchers will check participants’ SPMS and general health throughout the trial.
After treatment, participants will continue to have their health checked up to 1 month after receiving last dose.REC name
Wales REC 1
REC reference
25/WA/0318
Date of REC Opinion
12 Jan 2026
REC opinion
Further Information Favourable Opinion