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

Sponsor
M.B.A. van Doorn
Study ID
NCT03049267
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 10, 2017
Start date
Feb 2, 2017
Status verified
Jul 2018
Primary completion
Dec 6, 2017
Completion
Jun 28, 2018

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    N=15
  • Placebo Comparator: Placebo Oral Tablet
    N=5

Primary Outcome Measure

Change of expression levels of inflammatory cytokine mRNA in HS lesional skin. [ Time Frame: t=16 weeks ]

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