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NCT Number: NCT05906992

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis

This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis 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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CT-P53 3.1 investigational site

Poznan, Poland

Location status: Recruiting

About this study

CT-P53, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar efficacy, PK, PD and safety of CT-P53 and Ocrevus in patients with Relpasing-remitting Multiple Screlosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
  • Patient has evidence of recent MS activity as defined in the study protocol
  • Patient has neurological stability for ≥30 days.
  • Patient with 0 to 6.0 (both inclusive) on the EDSS score.

Exclusion criteria

  • Patient diagnosed with primary or secondary progressive MS.
  • Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
  • Patient unable to complete or has a contraindication to an MRI
  • Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
  • Patient who has currently or history of any of medical conditions described in the study protocol.
  • Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.

Treatment and study plan

CT-P53

Biological

Intravenous(IV) infusion

Other names: Ocrelizumab

US-Ocrevus

Biological

Intravenous(IV) infusion

Other names: Ocrelizumab

EU-Ocrevus

Biological

Intravenous(IV) infusion

Other names: Ocrelizumab

Primary outcomes

  1. Area under the concentration-time curve in PK group

    Time frame: Up to Week 24

    To demonstrate PK comparability in terms of the area under the concentration time curve in patients with RRMS as follows:

    • Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2)
    • Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24)

  2. Total number of new GdE lesions on T1-weighted brain MRI in Main study group

    Time frame: Up to Week 24

    To demonstrate the equivalence of CT-P53 to reference drug (EU-Ocrevus and US-Ocrevus) in terms of efficacy in patients with RRMS as determined by the total number of new gadolinium-enhancing (GdE) lesions on T1-weighted brain magnetic resonance imaging (MRI)

Secondary outcomes

  1. Absoulte CD19+ B-cell counts for PD assessments

    Time frame: Up to Week 96

    To assess PD of CT-P53 and reference drug (EU-Ocrevus and US-Ocrevus) as follows:

    • Absolute CD19+ B-cell counts

  2. Area under the concentration-time curve in PK group

    Time frame: Up to Week 16

    Area under the concentration-time curve from time zero to Week 16

  3. Total body clearance in PK group

    Time frame: Up to Week 2

    Total body clearance covering both administrations at Weeks 0 and 2 (CL)

  4. Volume of distribution at steady state in PK group

    Time frame: Up to Week 2

    Volume of distribution at steady state covering both administrations at Week 0 and 2 (Vss)

  5. Safety: Immunogenecity

    Time frame: Up to Week 96

    Number and percentage of patients with positive antidrug-antibody and neutralizing antibody results

  6. Annualized Relapse Rate (ARR)

    Time frame: Up to Week 96

    The total number of protocol-defined MS relapses for each patient will be counted and listed. Annualized relapse rate (ARR) will be calculated by the total number of protocol-defined relapses for all patients divided by time-in-study by patient.

  7. Change in Expanded Disability Status Score (EDSS)

    Time frame: Up to Week 96

    The EDSS score will be listed and descriptive statistics for actual value and change in EDSS score from baseline to Weeks 24, 48 and 96 will be summarized by treatment group and visit.

    An increase ≥1.5 point from baseline EDSS score is defined as disability progression.

    A reduction ≥1.0 point from baseline EDSS score is defined as disability improvement.

  8. Change in Multiple Sclerosis Functional Composite Score (MSFCS)

    Time frame: Up to Week 96

    There are three components to the MSFCS; (1) the average scores of two trials of T25-FW (2) the average scores on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged) (3) the number of correct answers from the PASAT-3. Multiple Sclerosis Functional Composite Score (MSFCS) is based on the concept that scores for these three dimensions (arm, leg, and cognitive functions) are combined to create a single score (the MSFCS) that can be used to detect change over time in MS patients

  9. Total Number of Lesions on Brain Magnetic Resonance Imaging

    Time frame: Up to Week 96

    The total number of lesions on brain MRI will be calculated as the cumulative sum of the individual number of the lesions at each scheduled visit

  10. Volume of Hypointense Lesions on T1-weighted Brain Magnetic Resonance Imaging

    Time frame: Up to Week 96

    Actual value of volume of hypointense lesions on T1-weighted brain MRI will be listed by treatment group and visit. Descriptive statistics for actual value and change in volume of hypointense lesions on T1-weighted brain MRI from baseline to Weeks 24, 48 and 96 will be summarized by treatment group

  11. Brain Volume on Brain Magnetic Resonance Imaging

    Time frame: Up to Week 96

    Change in brain volume is defined as the brain volume at pre-specified time point minus brain volume at baseline. Actual value of brain volume on brain MRI will be listed by treatment group. Descriptive statistics for actual value and percentage change in brain volume on brain MRI from baseline to Weeks 24, 48 and 96 will be summarized by treatment group.

  12. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Up to Week 96

    All reported terms of AEs will be coded to system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities (MedDRA) and severity grading of AEs will be recorded according to the CTCAE Version 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

JinHo Lee

CONTACT

[email protected]

+82 32 850 5787

SoYoung Yoo

CONTACT

[email protected]

+82 32 850 5791

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1/3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jun 18, 2023
Registry last updated
May 22, 2024

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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