Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Launched by AMGEN · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing a new medication called ABP 692 to an existing treatment known as Ocrevus® (ocrelizumab) for patients with relapsing-remitting multiple sclerosis (RRMS). The main goal of the study is to see if ABP 692 works similarly to Ocrevus in terms of how it acts in the body and its effectiveness in reducing new brain lesions, which are signs of MS activity. Researchers will use MRI scans to track any changes over a period of 24 weeks.

To be eligible for this trial, participants must have a confirmed diagnosis of RRMS and meet certain health criteria, including having a specific score on a disability scale. They should also be neurologically stable, meaning they haven't had a relapse in the last 28 days. Participants will be closely monitored throughout the study and will receive either ABP 692 or Ocrevus. This trial is currently recruiting individuals aged between 18 and 65, and both men and women can participate. If you or someone you know is interested in joining, it’s important to review the full eligibility requirements and discuss them with a healthcare provider.

Gender

ALL

Eligibility criteria

• 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.