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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Biological: CT-P43; Biological: Stelara

• Registration Number: NCT04673786
• Lead Sponsor: Celltrion

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.

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-17
• Study Start: 2021-01-11
• Primary Completion: 2021-08-04
• Study Completion: 2022-05-12
• Results First Submitted: 2023-05-03
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Results First Posted: 2023-06-05
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stelara	CT-P43	Patients who were initially randomized to Stelara group on Day 1 (Week 0) will be randomized again in a ratio of 1:1 to either continue Stelara or undergo transition to CT-P43 prior to dosing at Week 16. Thereafter, patients will continue their treatment until Week 40.
CT-P43	CT-P43	All patients who were initially randomized to the CT-P43 group on Day 1 (Week 0) will continue their treatment with CT-P43 until Week 40.
Stelara	Stelara	Patients who were initially randomized to Stelara group on Day 1 (Week 0) will be randomized again in a ratio of 1:1 to either continue Stelara or undergo transition to CT-P43 prior to dosing at Week 16. Thereafter, patients will continue their treatment until Week 40.

Primary Outcome Measures

Name	Time	Method
The Mean Percent Improvement From Baseline in PASI Score at Week 12	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 Outcome Measures

Name	Time	Method
The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12	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).
The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12	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.
The PASI Scores at Week 12	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).
The Mean Percent Improvement From Baseline in PASI Score Through Week 52	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).
The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52	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).

Trial Locations

Locations (1)

Clinical Research Centre; 🇪🇪 Tartu, Tartu Country, Estonia, Estonia