RECRUITING

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-01-13
Study Completion:2027-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06700343

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
  2. 2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
  3. 3. Evidence of recent MS activity as defined by the study protocol.
  4. 4. Neurologically stable subject, with no relapse for ≤ 28 days before randomization.
  1. 1. Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
  2. 2. Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
  3. 3. Any contraindications to study procedures or medications as outlined in the study protocol.
  4. 4. Any prohibited medication as defined in the study protocol.
  5. 5. Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
  6. 6. Current or history of any significant medical conditions as described in the study protocol.
  7. 7. Any abnormal laboratory blood values as defined in the study protocol.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Profound Research - Neurology Center of Southern California
Carlsbad, California, 92011
United States
Mountain Neurological Research Center
Basalt, Colorado, 81621
United States
Advanced Neurosciences Research, Llc
Fort Collins, Colorado, 80528
United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428
United States
Aqualane Clinical Research
Naples, Florida, 34105
United States
Palm Beach Medical Group
West Palm Beach, Florida, 33407
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
United States
Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills
Farmington, Michigan, 48334-2979
United States
University Of New Mexico School Of Medicine
Albuquerque, New Mexico, 87131
United States
The Boster Center for Multiple Sclerosis
Columbus, Ohio, 43235
United States
Premier Neurology, PC
Greenville, South Carolina, 29650
United States
Hope Neurology
Knoxville, Tennessee, 37922
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13
Study Completion Date2027-12-17

Study Record Updates

Study Start Date2025-01-13
Study Completion Date2027-12-17

Terms related to this study

Keywords Provided by Researchers

  • Neuroscience
  • Neurology
  • Neuroimmunology
  • Immunosuppressants
  • Ocrelizumab
  • ABP 692

Additional Relevant MeSH Terms

  • Relapsing-remitting Multiple Sclerosis (RRMS)