Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis
Status:
Completed
Trial end date:
2018-06-28
Target enrollment:
Participant gender:
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.