Comparing ABP 692 with Ocrevus for treating relapsing-remitting multiple sclerosis
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
PHASE3 · Amgen · NCT06700343
This study is testing if a new treatment called ABP 692 can work as well as Ocrevus for people with relapsing-remitting multiple sclerosis by looking at how it affects brain lesions over 24 weeks.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 444 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Amgen (industry) |
| Drugs / interventions | Ocrelizumab |
| Locations | 108 sites (Mobile, Alabama and 107 other locations) |
| Trial ID | NCT06700343 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the pharmacokinetics and pharmacodynamics of ABP 692 with Ocrelizumab, a well-established treatment for relapsing-remitting multiple sclerosis (RRMS). Participants will be assessed for the suppression of new active brain lesions over a 24-week period using magnetic resonance imaging (MRI). The study will include patients diagnosed with RRMS who meet specific inclusion criteria and will exclude those with certain contraindications or other forms of MS. The goal is to establish whether ABP 692 is a comparable alternative to Ocrelizumab.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with relapsing-remitting multiple sclerosis who are neurologically stable and meet the study's inclusion criteria.
Not a fit: Patients with primary progressive or secondary progressive multiple sclerosis, or those with significant medical conditions requiring chronic treatment with immunosuppressants, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a new, effective treatment option for relapsing-remitting multiple sclerosis.
How similar studies have performed: Other studies have shown success with similar approaches in comparing biosimilars to established treatments, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mobile, Alabama and 107 other locations
- University of South Alabama — Mobile, Alabama, United States (RECRUITING)
- Clinical Endpoints, LLC — Scottsdale, Arizona, United States (RECRUITING)
- Profound Research - Neurology Center of Southern California — Carlsbad, California, United States (RECRUITING)
- Mountain Neurological Research Center — Basalt, Colorado, United States (RECRUITING)
- Advanced Neurosciences Research, Llc — Fort Collins, Colorado, United States (RECRUITING)
- Hasbani Neurology — New Haven, Connecticut, United States (RECRUITING)
- Neurology Offices of South Florida — Boca Raton, Florida, United States (RECRUITING)
- Aqualane Clinical Research — Naples, Florida, United States (RECRUITING)
- Emerald Coast Neurology/Synergy Clinical Research — Pensacola, Florida, United States (RECRUITING)
- Knight Neurology — Rockledge, Florida, United States (RECRUITING)
- Premiere Research Institute Palm Beach — West Palm Beach, Florida, United States (RECRUITING)
- Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (RECRUITING)
- University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
- Henry Ford Health — Detroit, Michigan, United States (RECRUITING)
- Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills — Farmington, Michigan, United States (RECRUITING)
- JFK Medical Center — Edison, New Jersey, United States (RECRUITING)
- Hackensack Meridian Health — Paramus, New Jersey, United States (RECRUITING)
- University of NM/Mind Imaging center — Albuquerque, New Mexico, United States (RECRUITING)
- Triad Neurological Associates — Winston-Salem, North Carolina, United States (RECRUITING)
- Singlepoint Healthcare Opco, LLC — Columbus, Ohio, United States (RECRUITING)
- NDx Clinical Research, Inc — Dayton, Ohio, United States (RECRUITING)
- Premier Neurology, PC — Greenville, South Carolina, United States (RECRUITING)
- Hope Neurology — Knoxville, Tennessee, United States (RECRUITING)
- Vanderbilt University Medical Center (VUMC) — Nashville, Tennessee, United States (RECRUITING)
- Lone Star Neurology — Frisco, Texas, United States (RECRUITING)
- Froedtert Hospital-Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
- Algemeen Ziekenhuis Delta — Roeselare, West-Vlaanderen, Belgium (RECRUITING)
- MS-Netwerk Limburg - Revalidatie & MS Centrum — Overpelt, Belgium (RECRUITING)
- Diagnostic Consultative Center Convex Ltd — Sofia, Sofiiska, Bulgaria (RECRUITING)
- UMHAT Dr.Georgi Stranski EAD — Pleven, Bulgaria (RECRUITING)
- University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski — Sofia, Bulgaria (RECRUITING)
- Medical Center Hera EOOD — Sofia, Bulgaria (RECRUITING)
- UMHATEM N.I. Pirogov — Sofia, Bulgaria (RECRUITING)
- Foothills Medical Centre — Calgary, Alberta, Canada (RECRUITING)
- The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (RECRUITING)
- Sestre milosrdnice University Hospital Center — Zagreb, Croatia (RECRUITING)
- University Hospital Centre Zagreb — Zagreb, Croatia (RECRUITING)
- Fakultni nemocnice u sv. Anny v Brne — Brno, Czechia (RECRUITING)
- Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia (RECRUITING)
- Privatni ordinace neurologie — Hradec Králové, Czechia (RECRUITING)
- Regional Hospital Jihlava — Jihlava, Czechia (RECRUITING)
- Nemocnice Teplice — Teplice, Czechia (RECRUITING)
- Aarhus Universitetshospital, Skejby — Aarhus N, Central Jutland, Denmark (RECRUITING)
- Sydvestjysk Sygehus — Esbjerg, Region Syddanmark, Denmark (RECRUITING)
- Dansk Multipel Sklerose Center — Glostrup Municipality, Denmark (RECRUITING)
- Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau — Nîmes, France (RECRUITING)
- LTD Pineo Medical Ecosystem — Tbilisi, Georgia (RECRUITING)
- Jo Ann University Hospital — Tbilisi, Georgia (RECRUITING)
- Zentrum fur klinische Forschung Dr.Scholl — Bad Homburg, Germany (RECRUITING)
- Studienzentrum Dr. Bischof GmbH — Böblingen, Germany (RECRUITING)
+58 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsing-remitting Multiple Sclerosis, Neuroscience, Neurology, Neuroimmunology, Immunosuppressants, Ocrelizumab, ABP 692