Pfizer has started a Phase III clinical programme of its product candidate PF-04965842 for the treatment of patients with moderate-to-severe atopic dermatitis (AD).
PF-04965842 is an oral, small molecule, selective inhibitor of Janus kinase 1 (JAK1), and the inhibition is reported to regulate various cytokines that are involved in pathophysiology of the condition.
Pfizer has begun the programme with the pivotal B7451012 trial that is set to be initially carried out in North America, Australia and Europe, with plans for expansion in 2018.
The randomised, double-blind, placebo-controlled, parallel-group trial will assess the safety and efficacy of 100mg and 200mg once daily PF-04965842 over 12 weeks in 375 subjects aged 12 years and above.
Pfizer Global Product Development Inflammation & Immunology chief development officer Michael Corbo said: “By initiating this Phase III programme in atopic dermatitis, we hope to provide a new potential treatment option for people suffering with this condition.
“Pfizer continues to build a leadership position in inflammation and immunology research with the advancement of this important, Pfizer-discovered investigational oral JAK1 inhibitor.”
The primary endpoints of the Phase III B7451012 trial are proportion of patients experiencing an improvement in Investigator Global Assessment (IGA) score, and those achieving a minimum of 75% or greater change in the Eczema Area and Severity Index (EASI) score from baseline.
After the treatment period, patients can choose to remain in a safety follow-up period of four weeks or opt for a long-term extension study (B7451015) at Week 12.