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
- 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.
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 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 Actual PASI scores Up to 56 Weeks