A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Launched by CELLTRION · Dec 13, 2020
Trial Information
Current as of June 03, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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.
About Celltrion
Celltrion is a global biopharmaceutical company dedicated to the development and commercialization of innovative biologics and biosimilars. Founded in South Korea, Celltrion leverages advanced biotechnology to create high-quality therapeutics that address unmet medical needs in various therapeutic areas, including oncology, autoimmune diseases, and infectious diseases. With a strong commitment to research and development, Celltrion aims to enhance patient access to effective treatments while ensuring rigorous compliance with international regulatory standards. The company is recognized for its expertise in monoclonal antibody production and its pioneering role in the biosimilar market, positioning itself as a leader in the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tartu, Tartu Country, Estonia, Estonia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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