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Active, not recruiting Phase 3

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT06700343 · tracked via the Priya Life Science Turkey tracker
Sponsor
Phase
Phase 3
Started
2025-01-13
Last updated
2026-09-22

Condition(s) studied

Relapsing-remitting Multiple Sclerosis (RRMS)

Investigational drug(s) / intervention(s)

Ocrelizumab (US) →Ocrelizumab (EU) →ABP 692

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

Sex
ALL
Min age
18 Years
Max age
60 Years
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 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)

FacilityCityRegionStatus
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.

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 Turkey