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
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Poland
CT-P53 3.1 investigational site
RECRUITING
Poznan
Contact Information
Primary
SoYoung Yoo
soyoung.yoo@celltrion.com
+82 32 850 5791
Backup
JinHo Lee
jinho.lee2@celltrion.com
+82 32 850 5787
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2029-01
Participants
Target number of participants: 512
Treatments
Experimental: CT-P53
CT-P53(Ocrelizumab)
Active_comparator: US-Ocrevus
US-licensed Ocrevus(Ocrelizumab)
Active_comparator: EU-Ocrevus
EU-approved Ocrevus(Ocrelizumab)
Related Therapeutic Areas
Sponsors
Leads: Celltrion