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

Phase 3

Not yet recruiting

• Conditions: Plaque Psoriasis
• Interventions: Biological: CT-P55; Biological: EU-approved Cosentyx

• Registration Number: NCT06630559
• Lead Sponsor: Celltrion

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Start: 2025-04
• Primary Completion: 2025-12
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P55	CT-P55	-
EU-approved Cosentyx	CT-P55	-
EU-approved Cosentyx	EU-approved Cosentyx	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in Psoriasis Area and Severity Index (PASI) score	Week 12

Secondary Outcome Measures

Name	Time	Method
Actual PASI scores	Up to 56 Weeks
Percent change from baseline in PASI score	Up to 56 Weeks
Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100)	Up to 56 Weeks
Proportion of patients with IGA score of clear (0) or almost clear (1)	Up to 56 Weeks
Change from baseline in Dermatology Life Quality Index (DLQI)	Up to 56 Weeks