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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501622-37-00

Enrollment

432

Registered

2023-10-16

Start date

2024-01-16

Completion date

Unknown

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

For PK Group: Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2), For PK Group: Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24), For Main Study Group: Total number of new GdE lesions on T1-weighted brain MRI up to Week 48

Interventions

DRUGZirtek 1 mg/ml oral solution

DRUGOcrevus 300 mg concentrate for solution for infusion

DRUGParacetamol 500 mg HEXAL bei Fieber und Schmerzen

DRUG500 mg Tabletten

DRUGOCRELIZUMAB

DRUGSolu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 125 mg/vial.

DRUGCT-P53

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
For PK Group: Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2), For PK Group: Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24), For Main Study Group: Total number of new GdE lesions on T1-weighted brain MRI up to Week 48	—

Countries

Bulgaria, Croatia, Czechia, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026