Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis

Summary

Study design: A double-blind randomised placebo-controlled trial Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks. Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): * of patients receiving apremilast compared to placebo; * within both groups relative to baseline (t=0). Secondary objectives: * To prospectively evaluate the clinical efficacy of apremilast. * To assess the effect of apremilast on patient reported outcomes measures. * To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.

Timeline

Start

2017-02-02

Primary completion

2017-12-06

Completion

2018-06-28

Drugs

Indications