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

• Status: Completed
• Trial end date: 2018-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.B.A. van Doorn
• Collaborator: Celgene
• Treatments: Apremilast; Thalidomide

Criteria

Key inclusion criteria:

• Adult (≥ 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA);

• HS of more than 6 months duration; have lesions in at least two anatomical locations.

Key exclusion criteria:

• Contra-indication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS;

• Presence of other uncontrolled major disease;

• Pregnant or lactating women.