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

Sponsor
Celltrion
Study ID
NCT06630559
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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

Key Dates

Start date
May 26, 2025
Status verified
Feb 2026
Primary completion
Feb 18, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
153 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CT-P55
  • Active Comparator: EU-approved Cosentyx

Primary Outcome Measure

Percent change from baseline in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Week8 ]

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