A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-P53, US-Ocrevus, EU-Ocrevus.
- Who it may be relevant to
- Registry conditions: Relapsing-remitting Multiple Sclerosis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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.
Detailed description
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.
Interventions
- Biological CT-P53
Intravenous(IV) infusion - Biological US-Ocrevus
Intravenous(IV) infusion - Biological EU-Ocrevus
Intravenous(IV) infusion
Primary outcome measures
- Area under the concentration-time curve in PK group [Time frame: Up to Week 24]
- Total number of new GdE lesions on T1-weighted brain MRI in Main study group [Time frame: Up to Week 24]
Secondary outcome measures (12)
- Absoulte CD19+ B-cell counts for PD assessments [Time frame: Up to Week 96]
- Area under the concentration-time curve in PK group [Time frame: Up to Week 16]
- Total body clearance in PK group [Time frame: Up to Week 2]
- Volume of distribution at steady state in PK group [Time frame: Up to Week 2]
- Safety: Immunogenecity [Time frame: Up to Week 96]
- Annualized Relapse Rate (ARR) [Time frame: Up to Week 96]
- Change in Expanded Disability Status Score (EDSS) [Time frame: Up to Week 96]
- Change in Multiple Sclerosis Functional Composite Score (MSFCS) [Time frame: Up to Week 96]
- Total Number of Lesions on Brain Magnetic Resonance Imaging [Time frame: Up to Week 96]
- Volume of Hypointense Lesions on T1-weighted Brain Magnetic Resonance Imaging [Time frame: Up to Week 96]
- Brain Volume on Brain Magnetic Resonance Imaging [Time frame: Up to Week 96]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Up to Week 96]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- CT-P53 3.1 investigational site — Poznan
Identifiers
NCT: NCT05906992 · CT-P53 3.1