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Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT06700343

Active Not RecruitingPhase 3

Sponsor: Amgen

Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions: Ocrelizumab (US), Ocrelizumab (EU), ABP 692

Countries: United States, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, France

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (109)
  • Mobile, Alabama, United States
  • Scottsdale, Arizona, United States
  • Carlsbad, California, United States
  • Basalt, Colorado, United States
  • Fort Collins, Colorado, United States
  • New Haven, Connecticut, United States
  • Boca Raton, Florida, United States
  • Naples, Florida, United States
  • Pensacola, Florida, United States
  • Rockledge, Florida, United States
  • West Palm Beach, Florida, United States
  • Honolulu, Hawaii, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Detroit, Michigan, United States
  • Farmington, Michigan, United States
  • Edison, New Jersey, United States
  • Paramus, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Winston-Salem, North Carolina, United States
  • Columbus, Ohio, United States
  • Dayton, Ohio, United States
  • Greenville, South Carolina, United States
  • Knoxville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Frisco, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Roeselare, West-Vlaanderen, Belgium
  • Overpelt, Belgium
  • Sofia, Sofiiska, Bulgaria
  • + 79 more on CT.gov