An evolutionary tale on clinical trials in hidradenitis suppurativa.

Abstract

The therapeutic pipeline for moderate-to-severe hidradenitis suppurativa (HS) is robust. Successes and lessons learned have led to improvements in trial designs aimed at avoiding prior pitfalls, as well as high placebo response in HS, which remains a fundamental threat to drug development. Herein, we review the evolutions in HS trials over the last 20 years with respect to overall design, sample size, diversity in enrolment, inclusion criteria, concomitant medications, rescue therapy, endpoints and statistical design analysis plans. Areas of focus that merit future consideration are also highlighted.