Fezakinumab (anti-IL-22) treatment in adults with moderate-to-severe atopic dermatitis

We conducted a randomized, double-blind, placebo-controlled trial in adults with moderate-to-severe AD unresponsive to conventional topical or systemic treatment. Fezakinumab (ILV-094; anti IL-22 monoclonal antibody) monotherapy was administered for 12 weeks (primary endpoint), and clinical responses were followed until week 20. AD transcriptome significantly improved at week 12 in fezakinumab vs. placebo (p<1E-18). We conducted a phase IIa, randomized, double-blind, placebo-controlled, multi-center clinical trial to evaluate efficacy and safety of fezakinumab in patients with moderate-to-severe AD (clinicaltrials.gov #NCT01941537). Patients were randomly assigned to receive either intravenous fezakinumab or placebo (2:1 randomization to drug and placebo, respectively), with a loading dose of 600mg at baseline (day 0), followed by 300mg at weeks 2, 4, 6, 8, and 10. Primary outcome measures were assessed at week 12. Patients were followed up until week 20. Patients were enrolled at two sites in New York City, NY, USA. Biopsy specimens (lesional and non-lesional skin) were obtained before the first dose (day 0), and at weeks 4 and 12.