Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Phase 3

Not yet recruiting

• Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)
• Interventions: Drug: ABP 692; Drug: Ocrelizumab (US); Drug: Ocrelizumab (EU)

• Registration Number: NCT06700343
• Lead Sponsor: Amgen

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) 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 ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Study Start: 2025-01-31
• Primary Completion: 2027-01-15
• Study Completion: 2027-12-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 444

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABP 692	ABP 692	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.
Ocrelizumab (US)/ABP 692	Ocrelizumab (US)	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.
Ocrelizumab (US)/ABP 692	ABP 692	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.
Ocrelizumab (EU)	Ocrelizumab (EU)	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.

Primary Outcome Measures

Name	Time	Method
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)	Day 1 to Day 15
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of the Entire Initial Dose of IP	Day 1 to Day 15
Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)	Day 1
Cmax Following Infusion 2 of the Initial Dose of IP at Day 15 (Cmax, d15)	Day 15
AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP	Up to Week 16
AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)	Day 15 to Week 16
Time at Which Cmax, d1 (Tmax, d1) of IP is Observed	Day 1
Time at Which Cmax, d15 (Tmax, d15) of IP is Observed	Day 15
Trough Concentration (Ctrough) of IP at Day 15	Day 15
Clearance (CL) of IP	Up to Week 48
Volume of Distribution (Vd) of IP	Up to week 48
Terminal Elimination Half-life (T1/2) of IP	Up to Week 48
Mean Residence Time (MRT) of IP	Up to Week 48
Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI	Up to Week 24
Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI at Week 48	Week 48
Total Number of GdE T1-weighted Lesions per Brain MRI	Up to Week 24
Total Number of GdE T1-weighted Lesions per Brain MRI at Week 48	Week 48
Total Number of Combined Unique Active (CUA) Lesions per Brain MRI	Up to Week 24
Total Number of CUA Lesions per Brain MRI at Week 48	Week 48
Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24	Week 24
Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24	Week 24
Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48	Week 48
Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48	Week 48
Percentage of Participants who are Relapse-free at Week 24	Week 24
Percentage of Participants who are Relapse-free at Week 48	Week 48
Percentage of Participants with Anti-drug Antibodies (ADAs)	Up to Week 48
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Up to Week 96	An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination ...
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)	Up to Week 96
Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)	Up to Week 96

Trial Locations

Locations (11)

Profound Research - Neurology Center of Southern California; 🇺🇸 Carlsbad, California, United States

Mountain Neurological Research Center; 🇺🇸 Basalt, Colorado, United States

Advanced Neurosciences Research, Llc; 🇺🇸 Fort Collins, Colorado, United States

Neurology Offices of South Florida; 🇺🇸 Boca Raton, Florida, United States

Aqualane Clinical Research; 🇺🇸 Naples, Florida, United States

Palm Beach Medical Group; 🇺🇸 West Palm Beach, Florida, United States

Hawaii Pacific Neuroscience; 🇺🇸 Honolulu, Hawaii, United States

Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills; 🇺🇸 Farmington, Michigan, United States

The Boster Center for Multiple Sclerosis; 🇺🇸 Columbus, Ohio, United States

Premier Neurology, PC; 🇺🇸 Greenville, South Carolina, United States

Hope Neurology; 🇺🇸 Knoxville, Tennessee, United States