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

Phase 1 Completed 134 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2019-08-12
Primary completion: 2025-06-03
Completion: 2025-06-03

Publications

Newsome SD, Goldstick L, Robertson DS, Bowen JD, Naismith RT, Townsend B, Figueiredo C, Kletzl H, Giraudon M, Bortolami O, Zecevic D, Giacobino C, Clinch S, Shen YA, Deol-Bhullar G, Bermel RA. Subcutaneous ocrelizumab in multiple sclerosis: Results of the Phase 1b OCARINA I study. Ann Clin Transl Neurol. 2024 Dec;11(12):3215-3226. doi: 10.1002/acn3.52229. Epub 2024 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ocrelizumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Ocrelizumab	Monoclonal antibody	200 mg	Subcutaneous
Subject	Ocrelizumab	Monoclonal antibody	600 mg	Subcutaneous
Subject	Ocrelizumab	Monoclonal antibody	1200 mg	Subcutaneous
Background	rHuPH20	Protein / enzyme biologic	—	—

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

Summary

Timeline

Publications

Drugs

Indications