Compare ABP 692 & Ocrevus (Ocrelizumab) in Subjects with Relapsing-remitting Multiple Sclerosis

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety between ABP 692 and Ocrevus (Ocrelizumab) in Subjects with Relapsing-remitting Multiple Sclerosis

• IRAS ID

  1011113

• Contact name

  Amgen Inc. Amgen Inc.

• Contact email

  local_sponsor_services@iconplc.com

• Sponsor organisation

  Amgen Inc.

• Research summary

  The purpose of this study is to compare a new, investigational drug (biosimilar candidate) ABP 692 with an approved and marketed drug called Ocrevus® (ocrelizumab), in participants with relapsing-remitting multiple sclerosis (RRMS), to see if ABP 692 is similar to Ocrevus®. ABP 692 will be evaluated against Ocrevus® to assess comparability of drug concentrations in blood, its efficacy in managing the disease process in the brain, its side effects, and its overall tolerability compared to Ocrevus®.
  MS affects the brain and spinal cord. It cannot currently be cured, but treatment can help manage the symptoms and reduce disability progression. Patients with RRMS have flare-ups of symptoms where they get worse (relapse) and then go away or get better (remission). Over time, RRMS can develop into secondary progressive MS.
  The sponsor is Amgen Inc.
  ~444 participants will take part at ~125 research sites in ~20 countries.
  Patients aged ≥18 to ≤60 years with a diagnosis of RRMS, who had two or more documented relapses within the last 2 years, or one relapse within the last 1 year, or changes on their brain MRI scan related to RRMS in the last 6 months will be eligible to take part.
  Participants will be in the study for up to 64 weeks, but in some cases up to 100 weeks for additional safety monitoring. Participants will be assigned randomly to one of 3 groups:
  Group A 3 infusions of ABP 692
  Group B 2 infusions of US-ocrelizumab and 1 infusion of ABP 692
  Group C 3 infusions of EU-ocrelizumab
  There are 3 stages:
  Screening (no more than 28 days)
  Treatment (48 weeks)
  Follow-up Period (up to 48 weeks), depending on how quickly certain white blood cells will replenish in your blood
  The study will involve the following: demographics, medical history, physical examination (including weight, height and neurological function), vital signs, ECG, brain MRI, disease assessments, blood and urine tests, pregnancy test, study drug infusion and pre-medication

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  24/LO/0898

• Date of REC Opinion

  29 Jul 2025

• REC opinion

  Further Information Favourable Opinion