A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis

Celltrion509 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

509

Conditions

Psoriasis

Interventions

CT-P43BIOLOGICAL

45mg or 90mg dose subcutaneous administration

StelaraBIOLOGICAL

45mg or 90mg dose subcutaneous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Research Centre

Tartu, Tartu Country, Estonia, Estonia

Outcomes

Primary Outcomes

The Mean Percent Improvement From Baseline in PASI Score at 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).

Time frame: From baseline to Week 12

Secondary Outcomes

The PASI Scores at Week 12

The Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

Time frame: Week 12

The Mean Percent Improvement From Baseline in PASI Score Through Week 52

The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score through Week 52. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

Time frame: Through Week 52

The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12

The number of participants achieving at least 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

Time frame: Week 12

The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12

The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the erythema, average thickness, and scaling of all psoriatic lesions at a given time point. The sum of the 3 scales will be divided by 3 to obtain a final sPGA score.

Time frame: Week 12

The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52

This DLQI is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Total scores range from 0 to 30 (less to more impairment).

Data from ClinicalTrials.gov

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