NCT06700343

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

Conditions

• Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	Ocrelizumab (US)	IV infusion
DRUG	Ocrelizumab (EU)	IV infusion
DRUG	ABP 692	IV infusion

Timeline

• Start date: 2025-01-13
• Primary completion: 2027-01-15
• Completion: 2027-12-17
• First posted: 2024-11-22
• Last updated: 2026-04-13

Locations

107 sites across 22 countries: United States, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, France, Georgia, Germany, Italy, Lithuania, Poland, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study