NCT03972306

A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).

Conditions

• Multiple Sclerosis (MS)

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Administered by subcutaneous Injection
DRUG	Ocrelizumab	Administered by Intravenous (IV) Injection
DRUG	rHuPH20	Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab

Timeline

• Start date: 2019-08-12
• Primary completion: 2025-06-03
• Completion: 2025-06-03
• First posted: 2019-06-03
• Last updated: 2025-07-08

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study