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A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis

NCT05906992 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2024-05-22

No results posted yet for this 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.

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

BIOLOGICAL

CT-P53

Intravenous(IV) infusion

BIOLOGICAL

US-Ocrevus

Intravenous(IV) infusion

BIOLOGICAL

EU-Ocrevus

Intravenous(IV) infusion

Sponsors & Collaborators

Principal Investigators

  • Minji Ma · Celltrion, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2027-02-28
Completion
2029-01-31
FDA Drug
Yes

Countries

  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906992 on ClinicalTrials.gov