Status:
RECRUITING
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
Lead Sponsor:
Amgen
Conditions:
Relapsing-remitting Multiple Sclerosis (RRMS)
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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) si...
Eligibility Criteria
Inclusion
- Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
- Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
- Evidence of recent MS activity as defined by the study protocol.
- Neurologically stable subject, with no relapse for ≤ 28 days before randomization.
Exclusion
- Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
- Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
- Any contraindications to study procedures or medications as outlined in the study protocol.
- Any prohibited medication as defined in the study protocol.
- Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
- Current or history of any significant medical conditions as described in the study protocol.
- Any abnormal laboratory blood values as defined in the study protocol.
Key Trial Info
Start Date :
January 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2027
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT06700343
Start Date
January 13 2025
End Date
December 17 2027
Last Update
March 6 2026
Active Locations (105)
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1
University of South Alabama
Mobile, Alabama, United States, 36617
2
Clinical Endpoints, LLC
Scottsdale, Arizona, United States, 85258
3
Profound Research - Neurology Center of Southern California
Carlsbad, California, United States, 92011
4
Mountain Neurological Research Center
Basalt, Colorado, United States, 81621