NCT03049267

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

Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: M.B.A. van Doorn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rationale: Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions. Systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Apremilast	Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.
DRUG	Placebo Oral Tablet	Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.

Timeline

• Start date: 2017-02-02
• Primary completion: 2017-12-06
• Completion: 2018-06-28
• First posted: 2017-02-10
• Last updated: 2018-07-24

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study