Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Amgen

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)

Treatments: Drug: Ocrelizumab (EU); Drug: Ocrelizumab (US); Drug: ABP 692

Study type: Interventional

Funder types: Industry

Identifiers

NCT06700343

20230309

2024-512914-16 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 444 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
3. Evidence of recent MS activity as defined by the study protocol.
4. Neurologically stable subject, with no relapse for ≤ 28 days before randomization.

Exclusion criteria

1. Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
2. Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
3. Any contraindications to study procedures or medications as outlined in the study protocol.
4. Any prohibited medication as defined in the study protocol.
5. Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
6. Current or history of any significant medical conditions as described in the study protoc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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444 participants in 3 patient groups

ABP 692

Experimental group

Description:

Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose.

Treatment:

Drug: ABP 692

Ocrelizumab (US)/ABP 692

Experimental group

Description:

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692.

Treatment:

Drug: ABP 692

Drug: Ocrelizumab (US)

Ocrelizumab (EU)

Experimental group

Description:

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion.

Treatment:

Drug: Ocrelizumab (EU)