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

NCT06630559 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CT-P55 3.12024-513348-27
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week8

Secondary Outcomes (5)

• 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 Investigator's Global Assessment (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

Study Arms (2)

CT-P55

EXPERIMENTAL

Biological: CT-P55

EU-approved Cosentyx

ACTIVE COMPARATOR

Biological: CT-P55; Biological: EU-approved Cosentyx

Interventions

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).

CT-P55; EU-approved Cosentyx

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).

EU-approved Cosentyx

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.

Nadarzyn, Poland

Location

Study Officials

• Marek Krogulec

  Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 8, 2024
• Study Start: May 26, 2025
• Primary Completion: February 18, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

PL (1)