NCT05906992RecruitingPhase 3
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
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
Source: ClinicalTrials.gov · Last updated 22 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 512 (estimated)
- First submitted
- 9 May 2023
- Start date
- 11 Jan 2024
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Celltrion
- Diseases
- Multiple sclerosis
- NCT number
- NCT05906992
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 512
- From 11 Jan 2024 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CT-P53 3.1 investigational site Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.