Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Phase 3Active Not RecruitingNCT06700343

Amgen152 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

Ocrelizumab (US)DRUG

IV infusion

Ocrelizumab (EU)DRUG

IV infusion

ABP 692DRUG

IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 protocol. 7. Any abnormal laboratory blood values as defined in the study protocol.

Locations (109)

Outcomes

Primary Outcomes

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

Time frame: Day 1 to Day 15

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

Time frame: Day 1 to Week 16

Secondary Outcomes

Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)

Time frame: Day 1 to Day 15

Cmax Following Infusion 2 of theInitial Dose of IP at Day 15 (Cmax,d15)

Time frame: Day 15 to Week 16

AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP

Time frame: Day 1 to Week 16

AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)

Time frame: Day 15- Week 16

Time at Which Cmax, d1 (Tmax, d1) of IP is Observed

Time frame: Day 1 to Day 15

Time at Which Cmax, d15 (Tmax, d15) of IP is Observed

Time frame: Day 15 to Week 16

Trough Concentration (Ctrough) of IP at Day 15

Time frame: Day 15

Clearance (CL) of IP

Time frame: Day 1 to Week 16

Volume of Distribution (Vd) of IP

Data from ClinicalTrials.gov

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University of South Alabama

Mobile, Alabama, United States

Clinical Endpoints, LLC

Scottsdale, Arizona, United States

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

Hasbani Neurology

New Haven, Connecticut, United States

Neurology Offices of South Florida

Boca Raton, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Emerald Coast Neurology/Synergy Clinical Research

Pensacola, Florida, United States

Knight Neurology

Rockledge, Florida, United States

...and 99 more locations

Time frame: Day 1 to Week 16

Terminal Elimination Half-life (T1/2) of IP

Time frame: Day 1 to Week 16

Mean Residence Time (MRT) of IP

Time frame: Day 1 to Week 16

Total number of new gadolinium enhancing (GdE) T1-weighted lesions at week 12 and week 24

Time frame: Up to Week 24

Total number of GdE T1-weighted lesions at week 12 and week 24

Time frame: Up to Week 24

Total Number of New or Enlarging T2 Hyperintense Lesion at Week 12 and week 24

Time frame: Up to Week 24

Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24

Time frame: At Week 24

Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24

Time frame: At Week 24

Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48

Time frame: At Week 48

Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48

Time frame: At Week 48

Percentage of Participants who are Relapse-free at Week 24

Time frame: At Week 24

Percentage of Participants who are Relapse-free at Week 48

Time frame: At Week 48

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

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 product, medical device, or procedure. A TEAE is defined as an AE that starts or worsens on or after the first IP infusion up to the end of study visit.

Time frame: Up to Week 72

Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)

Time frame: Up to Week 72

Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)

Time frame: Up to Week 72

Percentage of Participants with Anti-drug Antibodies (ADAs)

Time frame: Up to Week 48