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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Biological: CT-P43; Biological: Stelara

Study type: Interventional

Funder types: Industry

Identifiers

NCT04673786

2020-001045-39 (EudraCT Number)

CT-P43 3.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 509 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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509 participants in 2 patient groups

CT-P43

Experimental group

Description:

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.

Treatment:

Biological: CT-P43

Stelara

Active Comparator group

Description:

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.

Treatment:

Biological: Stelara

Biological: CT-P43