Clinical trial NCT05906992: A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Area under the concentration-time curve in PK group
timeFrame: Up to Week 24
measure: Total number of new GdE lesions on T1-weighted brain MRI in Main study group
timeFrame: Up to Week 24
Secondary outcomes:
measure: Absoulte CD19+ B-cell counts for PD assessments
timeFrame: Up to Week 96
measure: Area under the concentration-time curve in PK group
timeFrame: Up to Week 16
measure: Total body clearance in PK group
timeFrame: Up to Week 2
measure: Volume of distribution at steady state in PK group
timeFrame: Up to Week 2
measure: Safety: Immunogenecity
timeFrame: Up to Week 96
measure: Annualized Relapse Rate (ARR)
timeFrame: Up to Week 96
measure: Change in Expanded Disability Status Score (EDSS)
timeFrame: Up to Week 96
measure: Change in Multiple Sclerosis Functional Composite Score (MSFCS)
timeFrame: Up to Week 96
measure: Total Number of Lesions on Brain Magnetic Resonance Imaging
timeFrame: Up to Week 96
measure: Volume of Hypointense Lesions on T1-weighted Brain Magnetic Resonance Imaging
timeFrame: Up to Week 96
measure: Brain Volume on Brain Magnetic Resonance Imaging
timeFrame: Up to Week 96
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: CT-P53 3.1 investigational site
Study officials:
affiliation: Celltrion, Inc.
name: Minji Ma
role: STUDY_CHAIR
References: