Actively Recruiting
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
Led by Celltrion · Updated on 2024-05-22
512
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple sclerosis according to the revised McDonald criteria
- Evidence of recent MS activity as defined in the study protocol
- Neurological stability for at least 30 days
- Expanded Disability Status Scale (EDSS) score between 0 and 6.0, inclusive
- Age between 18 and 55 years
You will not qualify if you...
- Diagnosed with primary or secondary progressive multiple sclerosis
- Diagnosed with MS for more than 15 years with an EDSS score of 2.0 or less at Screening
- Unable to complete or having contraindications to an MRI scan
- Contraindications or severe hypersensitivity to corticosteroids, methylprednisolone, study drug excipients, or related substances
- History or presence of medical conditions described in the study protocol
- Received or planned to receive prohibited medications or treatments as defined in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CT-P53 3.1 investigational site
Poznan, Poland
Actively Recruiting
Research Team
S
SoYoung Yoo
CONTACT
J
JinHo Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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