The Phase 3 study was a confirmatory, randomized, double-blind, active-control, parallel-group, 3-part trial evaluating CHS-1420 in patients with active, moderate to severe, chronic plaque psoriasis. Patients either received CHS-1420 or Humira in the first part of the study, followed by a cross-over section where half of Humira-treated patients will switch to CHS-1420 in treatment period 2. The primary study endpoint was the achievement of 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. Key secondary endpoints included comparative safety, including immunogenicity, and durability of response to CHS-1420 and Humira at Week 16 and 24.
Preliminary data shows that treatment with CHS-1420 demonstrates similar PASI-75 to Humira at Week 12, meeting the study’s primary endpoint. The 95% confidence intervals for the difference between treatment groups fell well within the prespecified margin. Similar safety and tolerability profiles were observed between the two treatment groups. Detailed results of the study will be presented at an upcoming scientific conference.
Following successful completion of the CHS-1420 trials, the company intends to file for BLA submission in the second half of 2016.
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