Short-term safety, efficacy and mode of action of apremilast in moderate suppurative hidradenitis suppurativa: a randomised double-blind placebo controlled trial.

Phase 2

Completed

Conditions: acne ectopica
acne inversa
10014982

Registration Number: NL-OMON42894

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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.

Exclusion Criteria

Contraindication 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The expression levels of inflammatory cytokine protein and mRNA in HS lesional<br /><br>skin will be analysed atweek four (t=4) and week sixteen (t=16) and compared<br /><br>between groups (apremilast and placebo). In addition, the expression levels at<br /><br>t=16 for each separate group will be compared relative to baseline (t=0). The<br /><br>proteins and genes of interest to be measured are IL-1β, IL-6, TNF-a, IL-10,<br /><br>IL-12, IL-23, IL-17A and IL-17F , IFN-γ, IL-31. Exactly the same cytokines will<br /><br>be measured using ELISA and qPCR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The clinical efficacy will be measured using the following scoring systems:<br /><br>• Individual inflammatory lesion count<br /><br>• HS-Physician Global Assessment (HS-PGA)<br /><br>• Hidradenitis Suppurativa Clinical Response (HiSCR)<br /><br><br /><br>The patient reported outcomes will be measured using the following scoring<br /><br>sytems:<br /><br>• NRS to assess pain, pruritus and patient disease global assessment score<br /><br>• DLQI<br /><br><br /><br>Other study parameters<br /><br>The following safety and tolerability parameters will be assessed:<br /><br>• Vital signs: heart rate, blood pressure, temperature.<br /><br>• Adverse events (every visit).<br /><br>• Safety laboratories: WBC (white blood cell count), ANC (absolute neutrophil<br /><br>count), Hemoglobin, Platelets, Serum Creatinine, ALT, Alkaline phosphatase.</p><br>