NCT06630559

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

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 With Cosentyx in Patients With Moderate to Severe Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	CT-P55	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).
BIOLOGICAL	EU-approved Cosentyx	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).

Timeline

• Start date: 2025-05-26
• Primary completion: 2026-02-18
• Completion: 2026-10-01
• First posted: 2024-10-08
• Last updated: 2026-02-23

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study