NCT05495568

To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 Study to Compare Pharmacokinetics, Efficacy and Safety of CT-P17 with Humira in Patients with Moderate to Severe Chronic Plaque Psoriasis

Detailed description

CT-P17 is a recombinant human monoclonal antibody containing the active ingredient adalimumab (human TNF-α blocker). CT-P17 is a drug product being developed by CELLTRION, Inc. and being compared to both the EU-approved Humira® and US-licensed Humira®. In this study, Pharmacokinetics, Efficacy and Safety of CT-P17 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.

Conditions

• Moderate to Severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	CT-P17	CT-P17 40mg will be subcutaneous administered
BIOLOGICAL	EU-approved Humira	subcutaneous administration

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-08-14
• Completion: 2024-02-05
• First posted: 2022-08-10
• Last updated: 2024-08-21

Locations

1 site across 1 country: Estonia