US pharma company Pfizer said that the phase 3 JADE COMPARE trial for abrocitinib in atopic dermatitis (AD) met its co-primary efficacy endpoints.
The late-stage study assessed the safety and efficacy of abrocitinib in adult patients with the skin condition, who were also on background topical therapy.
According to Pfizer, the investigational oral once-daily Janus kinase 1 (JAK1) inhibitor delivered improvements in skin clearance, disease extent and severity, and itch.
The phase 3 study also included an active control arm that was treated with dupilumab, which was administered subcutaneously and compared with placebo.
A total of 837 patients were randomly grouped to five treatment arms in the JADE COMPARE study.
Pfizer said that results from the JADE COMPARE trial showed that in comparison to placebo, there was a superiorly statistic percentage of patients who had achieved each co-primary efficacy endpoint at Week 12 with both doses of abrocitinib.
The company further said that dupilumab, the active control on the primary endpoints delivered superiority to placebo at Week 12 and Week 16.
Pfizer claimed that as a key secondary endpoint, the percentage of patients who showed a clinically significant reduction in itch by the second week of treatment was superior statistically for the 200mg abrocitinib dose compared to dupilumab and numerically higher, however not statistically significantly higher, for the 100mg dose of the investigational drug compared to dupilumab.
The safety profile for the investigational drug was in line with previous studies, said the US pharma company.
Pfizer global product development inflammation and immunology chief development officer Michael Corbo said: “It was helpful to study abrocitinib in combination with topical therapies to provide data relevant to the real-world setting.
“The addition of an active control was also important to better understand the significance of this potential new medicine and we’re encouraged by the positive data from this trial.”
In February 2018, the Pfizer’s drug candidate was granted breakthrough therapy designation from the US Food and Drug Administration for the treatment of patients with moderate to severe atopic dermatitis.