Active — Not RecruitingPhase 3

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

United States, Belgium, Bulgaria152 participantsStarted 2025-01-13

Plain-language summary

The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP)

Timeframe: Day 1 to Day 15

AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP

Timeframe: Day 1 to Week 16

Trial details

NCT IDNCT06700343

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-19

View on ClinicalTrials.gov More Relapsing-remitting Multiple Sclerosis (RRMS) trials