Eli Lilly and Company (Lilly) has commenced the IXORA-R head-to-head (H2H) clinical trial to investigate the efficacy and safety of Taltz (ixekizumab) in comparison with Tremfya (guselkumab) to treat adult patients with moderate-to-severe plaque psoriasis.
Psoriasis is a chronic, immune disease that impacts the skin.
Approximately 960 patients are expected to be included in the 24-week, multicentre, randomised, blinded, parallel-group trial.
The trial’s primary objective is the proportion of patients who achieve complete improvement from their baseline as measured by Psoriasis Area Severity Index (PASI) 100 at week 12.
Its secondary objectives include the proportion of patients achieving PASI 75 at week two, and PASI 100 at weeks four, eight and 24, as well as the proportion of patients achieving a Static Physician Global Assessment (sPGA) score of zero at week 12.
The trial is scheduled to be completed by the end of next year.
Eli Lilly and Company immunology development vice-president Lotus Mallbris said: “Lilly is committed to minimising the burden for people with immune-mediated inflammatory diseases, including moderate-to-severe plaque psoriasis.
“Head-to-head trials can provide robust evidence that helps advance clinical practice.”
IXORA-R is part of a broader clinical development programme conducted for Taltz in psoriatic disease.
Taltz is also being studied in a SPIRIT-H2H is a head-to-head clinical trial in comparison with Humira (adalimumab) in adult patients with psoriatic arthritis.
The study is expected to be concluded next year.
Taltz is a monoclonal antibody that is designed to selectively bind with interleukin 17A (IL-17A) cytokine and hinder its interaction with the IL-17 receptor.
IL-17A is a naturally occurring cytokine of normal inflammatory and immune responses.