Pfizer has reported positive results from the Phase III JADE MONO-1 clinical trial of its investigational Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients with moderate to severe atopic dermatitis.
The 12-week study compared a 200mg and 100mg dose of abrocitinib with placebo in 387 patients aged 12 years and over.
JADE MONO-1 forms part of Pfizer’s JADE global development programme.
The trial’s primary endpoint was the proportion of patients experiencing a score of clear (zero) or almost clear (one) skin on the Investigator Global Assessment (IGA), and a two-point or higher improvement relative to baseline.
The co-primary endpoint was the proportion of participants achieving at least a 75% or greater change in Eczema Area and Severity Index (EASI) score from baseline.
Key secondary endpoints were a four-point or greater decrease in itch severity on the pruritus numerical rating scale (NRS) and the magnitude of reduction in Pfizer’s pruritus and symptoms assessment for atopic dermatitis (PSAAD) scale.
Abrocitinib met all co-primary and secondary endpoints and displayed significant improvements in IGA, EASI-75, NRS ≥4-Point and EASI-90 response rates compared to placebo.
Improvements were observed to be significantly greater with both doses.
The most frequent abrocitinib-related treatment-emergent adverse events were short-lasting nausea, headache and nasopharyngitis, while subjects treated with placebo experienced dermatitis more frequently.
Pfizer Global Product Development Inflammation & Immunology chief development officer Michael Corbo said: “There is a critical need for additional treatment options for patients living with moderate to severe atopic dermatitis.
“We are pleased by these findings, which together with the recently reported positive top-line results from our second Phase III trial, encourage us that, if approved, abrocitinib may provide the first oral, once-daily treatment option for these patients.”
The company expects to report new data from the JADE programme early next year.