Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Description

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).

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

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Study Overview

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Study Details

Study overview

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).

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Condition
Relapsing-remitting Multiple Sclerosis (RRMS)
Intervention / Treatment

-

Contacts and Locations

Carlsbad

Profound Research - Neurology Center of Southern California, Carlsbad, California, United States, 92011

Basalt

Mountain Neurological Research Center, Basalt, Colorado, United States, 81621

Fort Collins

Advanced Neurosciences Research, Llc, Fort Collins, Colorado, United States, 80528

Boca Raton

Neurology Offices of South Florida, Boca Raton, Florida, United States, 33428

Naples

Aqualane Clinical Research, Naples, Florida, United States, 34105

West Palm Beach

Palm Beach Medical Group, West Palm Beach, Florida, United States, 33407

Honolulu

Hawaii Pacific Neuroscience, Honolulu, Hawaii, United States, 96817

Farmington

Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills, Farmington, Michigan, United States, 48334-2979

Albuquerque

University Of New Mexico School Of Medicine, Albuquerque, New Mexico, United States, 87131

Columbus

The Boster Center for Multiple Sclerosis, Columbus, Ohio, United States, 43235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-12-17