Orismilast for the treatment of mild to severe hidradenitis suppurativa: Week 16 data from OSIRIS, a Phase 2a, open-label, single-centre, single-arm, dose-finding clinical trial.

C G FrederiksenF B SedehElisabeth H Taudorf Ditte Marie Lindhardt Saunte Gregor Borut Ernst Jemec

Published in: Journal of the European Academy of Dermatology and Venereology : JEADV (2023)

Oral orismilast demonstrated a dose-dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted. The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021-000049-42).

Keyphrases

open label
clinical trial
phase ii
phase iii
study protocol
hidradenitis suppurativa
placebo controlled
double blind
phase ii study
randomized controlled trial
electronic health record
early onset
combination therapy
data analysis
artificial intelligence
smoking cessation