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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673786
• Other study ID #: CT-P43 3.1
• Secondary ID: 2020-001045-39
• Status: Completed
• Phase: Phase 3
• Start date: January 11, 2021
• Est. completion date: May 12, 2022

Study information

• Verified date: June 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: May 12, 2022
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• CT-P43
45mg or 90mg dose subcutaneous administration
• Stelara
45mg or 90mg dose subcutaneous administration

Locations

Country	Name	City	State
Estonia	Clinical Research Centre	Tartu	Tartu Country, Estonia

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From baseline to Week 12
Secondary	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).	Week 12
Secondary	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).	Through Week 52
Secondary	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).	Week 12
Secondary	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.	Week 12
Secondary	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).	Through Week 52