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

Celltrion Healthcare

Status and phase

Not yet enrolling

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 both 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

375 estimated 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.