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NCT Number: NCT06630559

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.

Nadarzyn, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT-P55

Biological

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 Cosentyx

Biological

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).

Primary outcomes

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

    Time frame: Week8

    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.

Secondary outcomes

  1. Actual PASI scores

    Time frame: Up to 56 Weeks

    Minimum 0 to Maximum 72 Higher scores mean a worse outcome

  2. Percent change from baseline in PASI score

    Time frame: Up to 56 Weeks

    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.

  3. 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

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

    Time frame: Up to 56 Weeks

  5. Change from baseline in Dermatology Life Quality Index (DLQI)

    Time frame: Up to 56 Weeks

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

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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