NCT04075266

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-09
• Primary completion: 2023-10-05
• Completion: 2029-12-01
• First posted: 2019-08-30
• Last updated: 2025-12-23
• Results posted: 2024-11-08

Locations

12 sites across 3 countries: United States, Italy, Poland

Regulatory

• FDA-regulated drug study