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

Phase 3Active Not RecruitingNCT06630559

Celltrion153 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

153

Conditions

Plaque Psoriasis

Interventions

CT-P55BIOLOGICAL

CT-P55, 300 mg by 2 subcutaneous (SC) injections of 150 mg/mL via Pre-Filled Syringe (PFS) every week for 5 doses (up to Week 4 after starting dose at Day 1), followed by every 4 weeks (Q4W) for 11doses (up to Week 48).

EU-approved CosentyxBIOLOGICAL

European Union (EU)-approved Cosentyx, 300 mg by 2 SC injections of 150 mg/mL via PFS every week for 5 doses (up to Week 4 after starting dose at Day 1), followed by Q4W for 11 doses (up to Week 48).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.

Nadarzyn, Poland

Outcomes

Primary Outcomes

Percent change from baseline in Psoriasis Area and Severity Index (PASI) score

A higher percent change indicates a better outcome. While the maximum value is 100%, the minimum value is not fixed and may be negative in cases of worsening symptoms.

Time frame: Week8

Secondary Outcomes

Actual PASI scores

Minimum 0 to Maximum 72 Higher scores mean a worse outcome

Time frame: Up to 56 Weeks

Percent change from baseline in PASI score

A higher percent change indicates a better outcome. While the maximum value is 100%, the minimum value is not fixed and may be negative in cases of worsening symptoms.

Time frame: 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)

Time frame: Up to 56 Weeks

Proportion of patients with Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1)

Time frame: Up to 56 Weeks

Change from baseline in Dermatology Life Quality Index (DLQI)

Minimum -30 to Maximum of 30 Higher scores indicate a worse outcome

Time frame: Up to 56 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.