BALLERUP, Denmark– LEO Pharma A/S – a global leader in medical dermatology – announced today that the first patient has been screened in the first head-to-head clinical trial to evaluate brodalumab (marketed in the European Union as Kyntheum®) compared with guselkumab (marketed globally as Tremfya®) in adult patients with moderate-to-severe plaque psoriasis who have an inadequate response to ustekinumab (marketed globally as Stelara®) treatment.
The COBRA (COmparing BRodalumab And guselkumab in ustekinumab inadequate responders) clinical trial is a randomized, double-blind, parallel-group, multinational study. The primary study endpoint is the proportion of patients who achieve PASI 100 (100% skin clearance) at week 16. The study further includes several secondary and exploratory endpoints, including the key secondary endpoint of time to PASI 100 response while on treatment for up to 28 weeks. PASI scores are used in clinical trials for psoriasis treatments to measure a change in disease severity.
“People with moderate-to-severe psoriasis benefit from complete skin clearance,” said Prof. Kristian Reich, Professor for Translational Research in Inflammatory Skin Disease at the University Medical Center Hamburg Eppendorf. “We have specifically designed this study to help understand which newer mechanism of action is the best option to help patients potentially achieve complete skin clearance when there is an insufficient response to older-generation biologics.”
Brodalumab is the only biologic treatment that selectively targets the interleukin-17 (IL-17) receptor subunit A.1 The IL-17 cytokines – a family of proteins involved in immune responses – send signals through the IL-17 receptors, which cause the inflammation associated with psoriasis.2
Guselkumab is a biologic treatment that selectively targets the interleukin 23 (IL-23) cytokine. IL-23 affects the differentiation, expansion, and survival of T cell subsets and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease.3
“We look forward to learning how brodalumab, in comparison with a treatment that targets the IL-23 pathway, can offer benefits to patients who no longer respond to less targeted therapies,” said Dr. Per Sproegel, Vice President, Medical Sciences, Global Research & Development, LEO Pharma.
