A Phase 3 clinical trial comparing CT-P55, a potential biosimilar, with EU-approved Cosentyx (secukinumab) in patients with moderate to severe plaque psoriasis, reached its primary completion date on 2026-02-18. This milestone indicates that data collection for the trial's main objectives has concluded.

Background

Secukinumab, marketed as Cosentyx, is an established biologic therapy used in the treatment of various inflammatory conditions, including plaque psoriasis. It targets interleukin-17A (IL-17A), a cytokine involved in inflammation. Biosimilars, such as CT-P55, are developed to be highly similar to an already approved reference biologic product, with no clinically meaningful differences in terms of safety, purity, and potency.

Trial design

The study (NCT06630559) is a Phase 3 clinical trial designed to compare the efficacy and safety of CT-P55 with Cosentyx. It enrolled 153 participants diagnosed with moderate to severe plaque psoriasis. The trial's primary objective is to evaluate how well CT-P55 performs against EU-approved Cosentyx in this patient population, focusing on key efficacy and safety parameters.

What this means

The completion of the primary study for this Phase 3 trial signifies a major milestone in the development of CT-P55, a potential biosimilar to Secukinumab. For clinicians and patient advocates, this means that the core data collection phase comparing the biosimilar to the reference product for moderate to severe plaque psoriasis is now complete. The next step will be the analysis and eventual release of the efficacy and safety results, which will be crucial for determining the biosimilar's equivalence or non-inferiority to Cosentyx. These findings will be important for expanding treatment options and potentially increasing access to therapies for psoriasis patients.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06630559, titled "A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis," was posted on 2026-02-18 on clinicaltrials.gov.