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

M

M.B.A. van Doorn

Status and phase

Completed
Phase 2

Conditions

Hidradenitis Suppurativa

Treatments

Drug: Apremilast
Drug: Placebo Oral Tablet

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03049267
SMASH trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Apremilast
Experimental group
Description:
N=15
Treatment:
Drug: Apremilast
Placebo Oral Tablet
Placebo Comparator group
Description:
N=5
Treatment:
Drug: Placebo Oral Tablet

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems