Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Last updated: May 13, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

Scar Tissue

Treatment

ABP 692

Ocrelizumab (EU)

Ocrelizumab (US)

Clinical Study ID

NCT06700343
20230309
2024-512914-16
  • Ages 18-60
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson etal, 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

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 ExpandedDisability Status Scale (EDSS) score of ≤ 2.5 at screening.

  3. Any contraindications to study procedures or medications as outlined in the studyprotocol.

  4. Any prohibited medication as defined in the study protocol.

  5. Any significant concomitant disease that may require chronic treatment with systemiccorticosteroids and/or systemic immunosuppressants during the study.

  6. Current or history of any significant medical conditions as described in the studyprotocol.

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

Study Design

Total Participants: 444
Treatment Group(s): 3
Primary Treatment: ABP 692
Phase: 3
Study Start date:
January 13, 2025
Estimated Completion Date:
December 17, 2027

Connect with a study center

  • Jo Ann Medical Center

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LTD Pineo Medical Ecosystem

    Tbilisi, 114
    Georgia

    Active - Recruiting

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Centre of Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Clinic of Neurology, University Clinical Center Nis

    Nis, 18000
    Serbia

    Active - Recruiting

  • Ospedale Regionale di Lugano, Sede Civico

    Lugano, 6903
    Switzerland

    Active - Recruiting

  • Profound Research - Neurology Center of Southern California

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Mountain Neurological Research Center

    Basalt, Colorado 81621
    United States

    Active - Recruiting

  • Advanced Neurosciences Research, Llc

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Neurology Offices of South Florida

    Boca Raton, Florida 33428
    United States

    Active - Recruiting

  • Aqualane Clinical Research

    Naples, Florida 34105
    United States

    Active - Recruiting

  • Emerald Coast Neurology, Synergy Clinical Research

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Emerald Coast Neurology/Synergy Clinical Research

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Palm Beach Medical Group

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills

    Farmington, Michigan 48334-2979
    United States

    Active - Recruiting

  • University Of New Mexico School Of Medicine

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • The Boster Center for Multiple Sclerosis

    Columbus, Ohio 43235
    United States

    Active - Recruiting

  • Neurology Diagnostics, Inc

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • Neurology Diagnostics, Inc.

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • Premier Neurology, PC

    Greenville, South Carolina 29650
    United States

    Active - Recruiting

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

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