NCT04966338

Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis

A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Cinnagen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS). All the participants will receive one of the following regimens: Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks. The primary objective of this study is to verify the equivalency of Ocrelizumab (CinnaGen) versus Ocrevus® (Roche, Switzerland) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.

Conditions

• Multiple Sclerosis
• Relapsing-Remitting

Interventions

Type	Name	Description
BIOLOGICAL	Ocrelizumab (CinnaGen, Iran)	Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.
BIOLOGICAL	Ocrelizumab (Roche, Switzerland)	Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.

Timeline

• Start date: 2019-08-19
• Primary completion: 2020-11-09
• Completion: 2021-10-01
• First posted: 2021-07-19
• Last updated: 2022-10-18

Locations

15 sites across 1 country: Iran