NCT03049267: SMASH

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

Completed Phase 2 Last updated 24 July 2018

What this trial tests

Phase 2 trial testing Apremilast in Hidradenitis Suppurativa in 20 participants. Completed in 28 June 2018.

Timeline

2 February 2017

Primary endpoint
6 December 2017

28 June 2018

Quick facts

Lead sponsor	M.B.A. van Doorn
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	2 February 2017
Primary completion	6 December 2017
Estimated completion	28 June 2018
Sites	1 location across Netherlands

Drugs / interventions tested

• Apremilast (APREMILAST) — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

M.B.A. van Doorn

Who can join

18 and older, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytokine Pathways and Investigational Target Therapies in Hidradenitis Suppurativa.
   Del Duca E, Morelli P, Bennardo L, Di Raimondo C, et al · · 2020 · cited 52× · PMID 33182701 · DOI 10.3390/ijms21228436
2. Apremilast for moderate hidradenitis suppurativa: no significant change in lesional skin inflammatory biomarkers.
   Vossen ARJV, van der Zee HH, Davelaar N, Mus AMC, et al · · 2019 · cited 17× · PMID 30451329 · DOI 10.1111/jdv.15354