RecruitingPhase 3

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

United States444 participantsStarted 2025-01-13

Plain-language 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).

Who can participate

Age range18 Years – 99 Years

SexALL

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.
✕. Any abnormal laboratory blood values as defined in the study protocol.

What they're measuring

Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP)

Timeframe: Day 1 to Day 15

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

Timeframe: Day 1 to Day 15

Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI

Timeframe: Up to Week 24

Trial details

NCT IDNCT06700343

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-15

Contact for this trial

Amgen Call Center

866-572-6436 medinfo@amgen.com

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

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

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.
✕. Any abnormal laboratory blood values as defined in the study protocol.

What they're measuring

Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP)

Timeframe: Day 1 to Day 15

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

Timeframe: Day 1 to Day 15

Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI

Timeframe: Up to Week 24