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

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04673786
• Collaborator: (none)
• Enrollment: 509
• Location: 1
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site Per Month: 31.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Biological: CT-P43; Biological: Stelara	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 509 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 11, 2021
• Actual Primary Completion Date: Aug 4, 2021
• Actual Study Completion Date: May 12, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. demonstrate efficacy equivalence [from baseline to Week 12]

   mean percent improvement in Psoriasis Area and Severity Index (PASI) score of CT-P43 and Stelara. PASI score ranges from 0 to 72. The higher the score, the more severe the disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Centre	Tartu	Tartu Country, Estonia	Estonia	50106

Sponsors and Collaborators

• Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT04673786
• Other Study ID Numbers: CT-P43 3.1; 2020-001045-39
• First Posted: Dec 17, 2020
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis; Ustekinumab

Study Results

No Results Posted as of Jun 1, 2022