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ACTIVE NOT RECRUITING
NCT04075266
PHASE2

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Official title: An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2020-01-09

Completion Date

2029-12-01

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DRUG

Ocrelizumab

Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks. Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg

Locations (12)

University of Colorado Denver Childrens Hospital Rocky Mountain MS Center

Aurora, Colorado, United States

Childrens National Health Center

Washington D.C., District of Columbia, United States

Boston Childrens Hospital

Boston, Massachusetts, United States

Washington Universtiy school of Medicine

St Louis, Missouri, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ospedale Pediatrico Bambino Gesù

Rome, Lazio, Italy

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, Italy

AOU Policlinico V. Emanuele - P.O G. Rodolico

Catania, Sicily, Italy

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, Poland

Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego

Warsaw, Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Poland