A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis

Celltrion Healthcare

Status and phase

Active, not recruiting

Phase 3

Conditions

Plaque Psoriasis

Treatments

Biological: EU-approved Cosentyx

Biological: CT-P55

Study type

Interventional

Funder types

Industry

Identifiers

NCT06630559

2024-513348-27 (EudraCT Number)

CT-P55 3.1

Details and patient eligibility

About

The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P55 with Cosentyx in patients with moderate to severe plaque psoriasis

Full description

CT-P55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. CT-P55 is a drug product being developed by CELLTRION, Inc. and being compared to the EU-approved Cosentyx®. In this study, Efficacy and Safety of CT-P55 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.

Enrollment

153 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.

Exclusion criteria

Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis.
Patient who has previously received Secukinumab or any other biologic drug directly targeting Interleukin-17 or the IL-17 receptor.
Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.