Clinical Trials in Poland / NCT06700343
Active, not recruiting
Phase 3
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
NCT06700343 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Relapsing-remitting Multiple Sclerosis (RRMS)
Investigational drug(s) / intervention(s)
Ocrelizumab (US): IV infusion
Ocrelizumab (EU): IV infusion
ABP 692: IV infusion
Study summary
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
Eligibility
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.
Primary outcome measure(s)
- Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP) — Day 1 to Day 15
- AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP — Day 1 to Week 16
Trial sites (109)
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Alabama | Mobile | Alabama | |
| Clinical Endpoints, LLC | Scottsdale | Arizona | |
| Profound Research - Neurology Center of Southern California | Carlsbad | California | |
| Mountain Neurological Research Center | Basalt | Colorado | |
| Advanced Neurosciences Research, Llc | Fort Collins | Colorado | |
| Hasbani Neurology | New Haven | Connecticut | |
| Neurology Offices of South Florida | Boca Raton | Florida | |
| Aqualane Clinical Research | Naples | Florida | |
| Emerald Coast Neurology/Synergy Clinical Research | Pensacola | Florida | |
| Knight Neurology | Rockledge | Florida | |
| Premiere Research Institute Palm Beach | West Palm Beach | Florida | |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | |
| Rush University Medical Center, Rush University Cancer Center | Chicago | Illinois | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Henry Ford Health | Detroit | Michigan | |
| Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills | Farmington | Michigan | |
| JFK Medical Center | Edison | New Jersey | |
| Hackensack Meridian Health | Paramus | New Jersey | |
| University of NM/Mind Imaging center | Albuquerque | New Mexico | |
| Triad Neurological Associates | Winston-Salem | North Carolina | |
| Singlepoint Healthcare Opco, LLC | Columbus | Ohio | |
| NDx Clinical Research, Inc | Dayton | Ohio | |
| Premier Neurology, PC | Greenville | South Carolina | |
| Hope Neurology | Knoxville | Tennessee | |
| Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee | |
| Lone Star Neurology | Frisco | Texas | |
| Froedtert Hospital-Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Algemeen Ziekenhuis Delta | Roeselare | West-Vlaanderen | |
| MS-Netwerk Limburg - Revalidatie & MS Centrum | Overpelt | Belgium | |
| Diagnostic Consultative Center Convex Ltd | Sofia | Sofiiska | |
| UMHAT Dr.Georgi Stranski EAD | Pleven | Bulgaria | |
| University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski | Sofia | Bulgaria | |
| Medical Center Hera EOOD | Sofia | Bulgaria | |
| UMHATEM N.I. Pirogov | Sofia | Bulgaria | |
| Foothills Medical Centre | Calgary | Alberta | |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | |
| Sestre milosrdnice University Hospital Center | Zagreb | Croatia | |
| University Hospital Centre Zagreb | Zagreb | Croatia | |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia | |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | Czechia |
+ 69 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06700343 on ClinicalTrials.gov ↗ ← All trials in Poland