A Randomized, Double-blind, Study to Demonstrate Pharmacokinetic Similarity, and Evaluate Safety, Immunogenicity, Pharmacodynamics and Clinical Effects between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects with Relapsing-remitting Multiple Sclerosis
Key facts
- Where
- Alcorcón, Barcelona, Castilleja De La Cuesta, Denia, Madrid, Malaga, Málaga, Salt, Sevilla, Valencia és Vigo, SpanyolországSee the 12 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Hospital Universitario Fundación AlcorcónAlcorcón, SpanyolországNo longer taking part
- Hospital Clinic de BarcelonaBarcelona, SpanyolországNo longer taking part
- Hospital Nisa Sevilla AljarafeCastilleja De La Cuesta, SpanyolországNo longer taking part
- Hospital De DeniaDenia, SpanyolországNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Vithas Parque San AntonioMalaga, SpanyolországNo longer taking part
- Hospital Universitario Regional de MálagaMálaga, SpanyolországNo longer taking part
- Hospital Santa Caterina IasSalt, SpanyolországNo longer taking part
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországNo longer taking part
- Hospital Universitario Dr. Peset AleixandreValencia, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
- Hospital Alvaro CunqueiroVigo, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen Inc.
- Trial code
- EU 2024-512914-16-00
- Record updated
- 2026. október 20.
- Original description
- Demonstrate PK similarity between ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU).Read full original descriptionShow less
- Demonstrate PK similarity between ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU).
Inclusion: Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017; Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive; Evidence of recent MS activity as defined by the study protocol; Neurologically stable subject, with no relapse for ≤ 28 days before randomization.
Exclusion: Any contraindications to study procedures or medications as outlined in the study protocol; Any prohibited medication as defined in the study protocol; Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study; Current or history of any medical conditions described in the study protocol; Any of the following abnormal laboratory blood values during screening: a. Total or conjugated bilirubin ≥ 1.5 times upper limit of normal (ULN) range. Subjects with Gilbert’s syndrome will be excluded. b. Aspartate aminotransferase or alanine transaminase ≥ 2 times ULN c. Amylase > ULN, range > 120 Somogyi units/dL or > 220 units/L (SI units), or according to the normal range of the central laboratory d. Lipase > ULN, range > 160 units/L or according to the normal range of the central laboratory e. Renal impairment defined as an estimated glomerular filtration rate ≤ 60 mL/min/1.73 m2 f. White blood cell count < 3500/mm3 (< 3.5 x 109 /L) g. Absolute neutrophil count ≤ 1500 cells/mm3 (≤ 1.5 x 109/L) i. Serum IgG and/or serum IgM < LLN (according to the normal range of the central laboratory) j. Any other clinically significant laboratory assessment as determined by the investigator (eg, significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function, etc); Multiple sclerosis disease duration of ≥ 10 years in subjects with EDSS score of ≤ 2.5 at screening; Diagnosis of PPMS according to the 2017 revision of the McDonald diagnostic criteria or with secondary progressive MS (Thompson et al, 2018).