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OpenTrials
Active, Not Recruiting

NCT Number: NCT06700343

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Relapsing-remitting Multiple Sclerosis (rrMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Algemeen Ziekenhuis Delta, Roeselare, West-Vlaanderen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
  • 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 criteria

  • Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
  • Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (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 significant medical conditions as described in the study protocol.
  • Any abnormal laboratory blood values as defined in the study protocol.

Treatment and study plan

Ocrelizumab (US)

Drug

IV infusion

Ocrelizumab (EU)

Drug

IV infusion

ABP 692

Drug

IV infusion

Primary outcomes

  1. Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP)

    Time frame: Day 1 to Day 15

  2. AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP

    Time frame: Day 1 to Week 16

Secondary outcomes

  1. Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)

    Time frame: Day 1 to Day 15

  2. Cmax Following Infusion 2 of theInitial Dose of IP at Day 15 (Cmax,d15)

    Time frame: Day 15 to Week 16

  3. AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP

    Time frame: Day 1 to Week 16

  4. AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)

    Time frame: Day 15- Week 16

  5. Time at Which Cmax, d1 (Tmax, d1) of IP is Observed

    Time frame: Day 1 to Day 15

  6. Time at Which Cmax, d15 (Tmax, d15) of IP is Observed

    Time frame: Day 15 to Week 16

  7. Trough Concentration (Ctrough) of IP at Day 15

    Time frame: Day 15

  8. Clearance (CL) of IP

    Time frame: Day 1 to Week 16

  9. Volume of Distribution (Vd) of IP

    Time frame: Day 1 to Week 16

  10. Terminal Elimination Half-life (T1/2) of IP

    Time frame: Day 1 to Week 16

  11. Mean Residence Time (MRT) of IP

    Time frame: Day 1 to Week 16

  12. Total number of new gadolinium enhancing (GdE) T1-weighted lesions at week 12 and week 24

    Time frame: Up to Week 24

  13. Total number of GdE T1-weighted lesions at week 12 and week 24

    Time frame: Up to Week 24

  14. Total Number of New or Enlarging T2 Hyperintense Lesion at Week 12 and week 24

    Time frame: Up to Week 24

  15. Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24

    Time frame: At Week 24

  16. Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24

    Time frame: At Week 24

  17. Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48

    Time frame: At Week 48

  18. Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48

    Time frame: At Week 48

  19. Percentage of Participants who are Relapse-free at Week 24

    Time frame: At Week 24

  20. Percentage of Participants who are Relapse-free at Week 48

    Time frame: At Week 48

  21. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Week 72

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAE is defined as an AE that starts or worsens on or after the first IP infusion up to the end of study visit.

  22. Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: Up to Week 72

  23. Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)

    Time frame: Up to Week 72

  24. Percentage of Participants with Anti-drug Antibodies (ADAs)

    Time frame: Up to Week 48

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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