Celltrion disclosed on Thursday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for modifications to its global Phase 3 clinical trial plan for CT-P55, a biosimilar to Cosentyx.
The clinical study is designed to evaluate the efficacy and safety of CT-P55 compared to Cosentyx in patients with moderate to severe plaque psoriasis. The trial will employ a randomized, active-controlled, double-blind methodology.
This amendment has reduced the number of trial participants from the initial 375 to 153. Over a 56-week period, the study aims to demonstrate biosimilarity by comparing the efficacy and safety outcomes of CT-P55 with those of the reference drug, Cosentyx.
It’s worth noting that Celltrion had previously received FDA approval for the global Phase 3 clinical trial plan for CT-P55 in 2024.