A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizuma… (NCT04544436) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
United States864 participantsStarted 2020-11-26
Plain-language summary
This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of RMS
* At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening. No relapse 30 days prior to screening and at baseline
* Participants must be neurologically stable for at least 30 days prior to randomization and baseline
* EDSS score, at screening and baseline, from 0 to 5.5 inclusive
* Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
* Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds
* Documented magnetic resonance imaging (MRI) of brain with abnormalities consistent with MS at screening
* Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization
* Females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods
* Female participants without reproductive potential may be enrolled e.g. if post-menopausal or if surgically sterile
Exclusion Criteria:
* History of primary progressive MS at screening
* Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antim…
What they're measuring
1
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)