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Biosimilar study comparing ABP 692 and Ocrevus® (Ocrelizumab) in RRMS

Multiple Sclerosis

ABP 692 is an investigational medication that is being developed to be similar to ocrelizumab. The OAK Study will test the pharmacokinetics (how the body absorbs, distributes, and processes the medication), pharmacodynamics (how the medication affects the body), clinical effects, and safety of the investigational ABP 692, compared to the FDA- and European Medicines Agency (EMA)-approved Ocrevus® (ocrelizumab) in people with relapsing-remitting multiple sclerosis.

Eligible participants will be assigned randomly (by chance) to receive one of the following treatments:
• 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.

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Conditions de participation

  • Sexe:

    Male, Female, Intersex

  • Âges admissibles:

    18 to 60

Critères de participation

Inclusion Criteria:
Inclusion Criteria:
You may be able to join the study if you:
• Are from 18 to 60 years old
• Have been diagnosed with RRMS
• Have had 1 of the following:
- Two or more relapses within the last 2 years
- One relapse within the last 12 months
- At least 1 MS-related lesion shown on magnetic resonance imaging (MRI) within the last 6 months
Exclusion Criteria:
Exclusion Criteria:
You may not be eligible to take part if you:
• Have been diagnosed with Progressive MS
• Have MS for more than 10 years and your Expanded Disability Status Scale (EDSS) score is ≤ 2.5
3. Any contraindications to study procedures or medications as outlined in the study protocol.
• Use any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
• Have significant medical conditions as per the study protocol.
• Presented abnormal laboratory blood values as per the study protocol.

Lieu de l'étude

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Étude parrainée par
University of Calgary
Participants recherchés
Plus d'informations
ID de l'étude: REB24-0233