Clinical Trials in Poland / NCT05906992
Recruiting
Phase 3
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
NCT05906992 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Relapsing-remitting Multiple Sclerosis
Investigational drug(s) / intervention(s)
CT-P53: Intravenous(IV) infusion
US-Ocrevus: Intravenous(IV) infusion
EU-Ocrevus: Intravenous(IV) infusion
Study 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.
Eligibility
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 outcome measure(s)
- Area under the concentration-time curve in PK group — 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 — 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)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CT-P53 3.1 investigational site | Poznan | Poland | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05906992 on ClinicalTrials.gov ↗ ← All trials in Poland