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Clinical Trial: Brain Shuttle CD20 inhibitor

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Details
Type of MS: PPMS|PRMS|RRMS|SPMS
Treatment mode of action: To affect immune function
Number of Subjects: 63
Medication: RO7121932 combines a CD20 inhibitor antibody with a “brain shuttle” module, which delivers it to the brain
Location: Connecticut|Massachusetts|New York|Rhode Island
Institutions: Yale University             
6 Devine St
North Haven, CT 06473
  Contact Information
Dimitri Duvilaire
203-287-6100
Dimitri.Duvilaire@yale.edu

Funding:

Roche

Description

RO7121932 is being developed for the possible treatment of MS. RO7121932 combines a CD20 inhibitor antibody with a “brain shuttle” module, which delivers it to the brain.
 
This clinical trial is a phase 1 study, recruiting people who have multiple sclerosis, but have not experienced a relapse or new MRI activity for 12 months. People with relapsing and progressive are eligible. The purpose of this clinical trial is to test the safety of RO7121932 at different doses and to understand the way the body processes it. Participants will do some tests to confirm they are suitable for the trial. Participants will come into the clinical trial unit for RO7121932 administration and stay for two nights so that their health can be monitored. They will be given one dose of RO7121932 via intravenous infusion. After leaving the clinical unit on the third day, there will be at least 10 outpatient hospital visits (six times in the first month and then four times, once per month over the next four months; the duration will vary depending on the procedures that will be performed). These hospital visits will include checks to see how participants are responding to the treatment and any side effects they may be having, as well as blood draws. The time commitment is approximately 24 weeks. Compensation is provided for the study.
 
You may be able to take part in this trial if you:
  • Are aged 18 to 65 years, inclusive.
  • Have non-active (have not experienced a relapse or new MRI activity for 12 months) MS: relapsing or progressive MS.
  • Are able to walk 5 meters or more with or without aid
  • Are not on any therapy for controlling MS or are not planning on starting any MS therapy for the whole trial duration. 
Patient website for the study: https://forpatients.roche.com/en/trials/neurodegenerative-disorder/multiple-sclerosis/a-clinical-trial-to-test-the-safety-of-ro7121932-at-different-do.html

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