Taking peoplePhase 3
Compares a biosimilar drug with Ocrevus in relapsing-remitting multiple sclerosis
Tests ABP 692, a copy of ocrelizumab, in adults with relapsing-remitting multiple sclerosis.
Key facts
- Who runs it
- Amgen Inc.
- Where
- Glostrup, DenmarkSee the siteAlso in 14 other countries, 54 sites
- Trial code
- EU 2024-512914-16-00
- U1111-1305-9272
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 125 people, planned
- Started
- 12 Sept 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsing-remitting multiple sclerosis (RRMS) who have had recent MS activity and are neurologically stable.
- Age
- 18 to 64 years
- Sex
- Women and men
- Disease stage
- Relapsing-remitting MS (RRMS) diagnosed by the revised McDonald Criteria 2017, with a disability score (EDSS) from 0 to 5.5 and recent MS activity as defined in the study protocol.
- Earlier treatment
- No relapse in the 28 days or less before randomization. Prohibited medicines named in the study protocol cannot be used.
Main reasons for not taking part
- Primary progressive MS or secondary progressive MS
- MS for 10 years or more with an EDSS score of 2.5 or lower
- Another illness that may need long-term steroids or immune-suppressing medicine during the study
- Abnormal blood test results at screening, such as liver, kidney, white cell or immunoglobulin values
- Any medical condition or medicine restriction listed in the study protocol
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Check if you might fit
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 Denmark
Also in 14 other countries, 54 sites
- RigshospitaletGlostrup, DenmarkNo longer taking part
About the trial
What the trial wants to find out
- Demonstrate PK similarity between ABP 692 and ocrelizumab (US), and ABP 692 and ocrelizumab (EU).
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Compares a biosimilar drug with Ocrevus in relapsing-remitting multiple sclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Fit questions
- Built from 2024-512914-16-00, who can take part
- Record updated
- 20 October 2026