Trial intelligence / Profile preview

Ocrelizumab Discontinuation in Early Relapsing Multiple Sclerosis

NCT05285891Phase 4

Key facts

Status: Active, not recruiting
Start: Feb 2023
Primary completion: Aug 2031
Countries: 1
Sponsor: National Institute of Allergy and Infectious Diseases
Modality: Monoclonal Antibodies

Drugs: ocrelizumab
Conditions: multiple sclerosis (MS)

Overview

Phase 4, randomised, double-blind trial in multiple sclerosis (MS) comparing Ocrelizumab Arm with Placebo Arm (2 arms). Primary endpoint: Absence of clinical relapse. Started Feb 2023; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Ocrelizumab Arm
Participants receive ocrelizumab during the open-label period and continue receiving ocrelizumab during the blinded period.
Placebo Arm
Participants receive ocrelizumab during the open-label period and switch to placebo during the blinded period.

Who it enrols

Patients with early relapsing multiple sclerosis (disease duration <= 3 years) who have not received certain prior MS disease-modifying therapies, with adequate organ function and no active infections or malignancies.

Endpoints

Primary

Absence of clinical relapseMonth 24 to Month 48

Secondary

Change in Expanded Disability Status Scale (EDSS) scoreMonth 24 to Month 48
Proportion of participants with a serious adverse event (SAE)Month 0 to Month 48
Proportion of participants who experience at least one Grade 3 or higher adverse eventMonth 0 to Month 48
Proportion of participants with infections, Grade 3 or higherMonth 0 to Month 48
Proportion of participants with malignanciesMonth 0 to Month 48
Proportion of participants experiencing infusion related reactionsMonth 0 to Month 48
Ratio of granulocyte-macrophage colony-stimulating factor (GM-CSF) expressing B-Cells to Interleukin 10 (IL-10) expressing B cellsMonth 48

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