A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Celltrion
- Enrollment
- 509
- Locations
- 1
- Primary Endpoint
- The Mean Percent Improvement From Baseline in PASI Score at Week 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.
Detailed Description
CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.
Exclusion Criteria
- •Patients diagnosed with forms of psoriasis other than plaque-type.
- •Patients previously received ustekinumab or a biosimilar of ustekinumab.
- •Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.
Outcomes
Primary Outcomes
The Mean Percent Improvement From Baseline in PASI Score at Week 12
Time Frame: From baseline to Week 12
The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Secondary Outcomes
- The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12(Week 12)
- The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12(Week 12)
- The PASI Scores at Week 12(Week 12)
- The Mean Percent Improvement From Baseline in PASI Score Through Week 52(Through Week 52)
- The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52(Through Week 52)