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

Phase 3RecruitingNCT05906992

Celltrion512 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

512

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

CT-P53BIOLOGICAL

Intravenous(IV) infusion

US-OcrevusBIOLOGICAL

Intravenous(IV) infusion

EU-OcrevusBIOLOGICAL

Intravenous(IV) infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

CT-P53 3.1 investigational site

Poznan, Poland

RECRUITING

Outcomes

Primary Outcomes

Area under the concentration-time curve in PK group

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)

Time frame: Up to Week 24

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

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)

Time frame: Up to Week 24

Secondary Outcomes

Absoulte CD19+ B-cell counts for PD assessments

To assess PD of CT-P53 and reference drug (EU-Ocrevus and US-Ocrevus) as follows: • Absolute CD19+ B-cell counts

Time frame: Up to Week 96

Area under the concentration-time curve in PK group

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

Time frame: Up to Week 16

Total body clearance in PK group

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

Time frame: Up to Week 2

Volume of distribution at steady state in PK group

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

Time frame: Up to Week 2

Safety: Immunogenecity

Central Contacts

SoYoung Yoo

CONTACT

+82 32 850 5791 soyoung.yoo@celltrion.com

JinHo Lee

CONTACT

+82 32 850 5787 jinho.lee2@celltrion.com

Data from ClinicalTrials.gov

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

Time frame: Up to Week 96

Annualized Relapse Rate (ARR)

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.

Time frame: Up to Week 96

Change in Expanded Disability Status Score (EDSS)

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.

Time frame: Up to Week 96

Change in Multiple Sclerosis Functional Composite Score (MSFCS)

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

Time frame: Up to Week 96

Total Number of Lesions on Brain Magnetic Resonance Imaging

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

Time frame: Up to Week 96

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

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

Time frame: Up to Week 96

Brain Volume on Brain Magnetic Resonance Imaging

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.

Time frame: Up to Week 96

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

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

Time frame: Up to Week 96