BIOSIMILAR · 20230309

Comparative analysis between the experimental drug ABP 692 and Ocrevus to examine their pharmacological properties, clinical reactions, and safety profile in individuals suffering from relapsing-remitting multiple sclerosis.

A randomized, double-blind, parallel-group study comparing the pharmacokinetics, pharmacodynamics, clinical effects, and safety of ABP 692 and Ocrevus (ocrelizumab) in participants with relapsing-remitting multiple sclerosis.

Sponsor: Amgen

Phase: III

Status: Follow-up

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Public study eligibility criteria

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

  • Diagnosis of PPMS according to the 2017 revision of the McDonald diagnostic criteria or with secondary progressive MS (Thompson et al, 2018).
  • Multiple sclerosis disease duration of ≥ 10 years in subjects with EDSS score of ≤ 2.5 at screening.
  • 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)