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Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT06700343 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2026-05-11

No results posted yet for this study

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

DRUG

Ocrelizumab (US)

IV infusion

DRUG

Ocrelizumab (EU)

IV infusion

DRUG

ABP 692

IV infusion

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-01-15
Completion
2027-12-17
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06700343 on ClinicalTrials.gov