Relapsing-remitting Multiple SclerosisPhase 3NCT05906992
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
A Phase 3 study testing CT-P53, US-Ocrevus and EU-Ocrevus in people with Relapsing-remitting Multiple Sclerosis, run by Celltrion at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- CT-P53, US-Ocrevus and EU-Ocrevus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 sitePoland
- Study dates
- 11 Jan 2024to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- CT-P53, US-Ocrevus, EU-Ocrevus
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P53Biological
Also called Ocrelizumab
Intravenous(IV) infusion
US-OcrevusBiological
Also called Ocrelizumab
Intravenous(IV) infusion
EU-OcrevusBiological
Also called Ocrelizumab
Intravenous(IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| CT-P53 | Experimental | CT-P53(Ocrelizumab) Receives: Biological: CT-P53 |
| US-Ocrevus | Active comparator | US-licensed Ocrevus(Ocrelizumab) Receives: Biological: US-Ocrevus |
| EU-Ocrevus | Active comparator | EU-approved Ocrevus(Ocrelizumab) Receives: Biological: EU-Ocrevus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Up to Week 24
Secondary outcomes (12)
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
Measured: 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
Measured: Up to Week 16
Total body clearance in PK group
Total body clearance covering both administrations at Weeks 0 and 2 (CL)
Measured: 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)
Measured: Up to Week 2
Safety: Immunogenecity
Number and percentage of patients with positive antidrug-antibody and neutralizing antibody results
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start11 Jan 2024
- Primary completionFeb 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minji Ma, Study chair, Celltrion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906992
- Sponsor's protocol ID
- CT-P53 3.1
- Status last verified
- May 2024
- First submitted
- 9 May 2023
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05906992
- Acronym / sponsor ID
- CT-P53 3.1
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT-P53 | Experimental | Biological: CT-P53CT-P53(Ocrelizumab) |
| US-Ocrevus | Active comparator | Biological: US-OcrevusUS-licensed Ocrevus(Ocrelizumab) |
| EU-Ocrevus | Active comparator | Biological: EU-OcrevusEU-approved Ocrevus(Ocrelizumab) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P53Also: OcrelizumabIntravenous(IV) infusion | Biological | CT-P53 |
| US-OcrevusAlso: OcrelizumabIntravenous(IV) infusion | Biological | US-Ocrevus |
| EU-OcrevusAlso: OcrelizumabIntravenous(IV) infusion | Biological | EU-Ocrevus |
Primary outcome
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)
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)
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minji Ma study chair
Celltrion, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P53, US-Ocrevus and EU-Ocrevus in people with Relapsing-remitting Multiple Sclerosis, run by Celltrion at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SoYoung Yoo (+82 32 850 5791, soyoung.yoo@celltrion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve in PK group (time frame: Up to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.