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
Amgen
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
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOcrelizumab (US)
IV infusion
- DrugOcrelizumab (EU)
IV infusion
- DrugABP 692
IV infusion
Locations (107)
- University of South AlabamaMobile, Alabama
- Clinical Endpoints, LLCScottsdale, Arizona
- Profound Research - Neurology Center of Southern CaliforniaCarlsbad, California
- Mountain Neurological Research CenterBasalt, Colorado
- Advanced Neurosciences Research, LlcFort Collins, Colorado
- Hasbani NeurologyNew Haven, Connecticut