MSFrontier

20230309

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
Running, not recruitingPhase 3Relapsing MSNCT067003432024-512914-16-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • ABP 692
  • Ocrelizumab

    B-lymphocyte antigen CD20 binding agent

Compared with

What it measured

Main measures

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

    Day 1 to Day 15

    How the body handles the medicine

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

    Day 1 to Week 16

    How the body handles the medicine

Other measures (24)

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

    Day 1 to Day 15

    How the body handles the medicine

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

    Day 15 to Week 16

    How the body handles the medicine

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

    Day 1 to Week 16

    How the body handles the medicine

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

    Day 15- Week 16

    Immune responseHow the body handles the medicine

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

    Day 1 to Day 15

    How the body handles the medicine

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

    Day 15 to Week 16

    How the body handles the medicine

  • Trough Concentration (Ctrough) of IP at Day 15

    Day 15

    How the body handles the medicine

  • Clearance (CL) of IP

    Day 1 to Week 16

    How the body handles the medicine

  • Volume of Distribution (Vd) of IP

    Day 1 to Week 16

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

    Day 1 to Week 16

    MRI lesionsHow the body handles the medicine

Who could take part

Relapsing MS · 18 to 60

Inclusion Criteria: 1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018). 2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive. 3. Evidence of recent MS activity as defined by the study protocol. 4. Neurologically stable subject, with no relapse for ≤ 28 days before randomization. Exclusion Criteria: 1. Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018). 2. Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening. 3. Any contraindications to study procedures or medications as outlined in the study protocol. 4. Any prohibited medication as defined in the study protocol. 5. Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study. 6. Current or history of any significant medical conditions as described in the study protocol. 7. Any abnormal laboratory blood values as defined in the study protocol.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

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Related trials

History

    1. Started

      Jan 2025

    2. Main results due

      Apr 2027

    3. Finished

      Oct 2027

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