A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
Recruiting · NCT05906992 · Interventional (participants receive a specific treatment) · Lead sponsor: Celltrion
View the official record on ClinicalTrials.gov →Interventions studied
CT-P53EU-OcrevusUS-Ocrevus
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- CT-P53 3.1 investigational site - Poznan, Poland