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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: CT-P43; Biological: Stelara

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 Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 3

Contacts and Locations

Study Locations

• Estonia
  • Tartu Country, Estonia
    • Tartu, Tartu Country, Estonia, Estonia, 50106
      • Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: CT-P43; 45mg or 90mg dose subcutaneous administration
Active Comparator: 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.	Biological: CT-P43; 45mg or 90mg dose subcutaneous administration; Biological: Stelara; 45mg or 90mg dose subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): May 12, 2022

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: CT-P43 3.1; 2020-001045-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No