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NCT Number: NCT03049267

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

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasmus University Medical Center

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.

Other names: Otezla, CC-10004

Placebo oral tablet

Drug

Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.

Other names: Placebo comparator

Primary outcomes

  1. Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.

    Time frame: t=16 weeks

    measurement by qPCR

  2. Change of expression levels of inflammatory cytokine protein in HS lesional skin.

    Time frame: t=16 weeks

    measurement by ELISA

Secondary outcomes

  1. Abscesses count

    Time frame: t=0 weeks, t=4 weeks, t=16 weeks

    Total number of abscesses [A]

  2. Nodule count

    Time frame: t=0 weeks, t=4 weeks, t=16 weeks

    Total number of inflammatory [N] and non-inflammatory nodules

  3. Fistula count

    Time frame: t=0 weeks, t=4 weeks, t=16 weeks

    Total count of draining fistulas

  4. Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score

    Time frame: t=0 weeks, t=4 weeks, t=16 weeks

    Based on the HS lesion count

  5. Hidradenitis Suppurativa Clinical Response (HiSCR)

    Time frame: t=0 weeks, t=16 weeks

    Based on the AN count; The proposed definition of 50% and 30% responders to treatment (HiSCR achievers) is respectively: (i) at least a 50% and 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline.

  6. Numerical Rating Scale (NRS)

    Time frame: t=0 weeks, t=4 weeks, t=16 weeks

    To assess the patient reported outcome measures (PROMs) pain, pruritus and patient disease global assessment score;

  7. Dermatology Life Quality Index (DLQI)

    Time frame: t=0 weeks, t=4 weeks, t=16 weeks

    To assess the patient reported outcome measures (PROM) quality of life

  8. Incidence of Treatment-Emergent Adverse Events

    Time frame: Multiple time points between t=0 weeks and t=16 weeks

    Vital signs: heart rate, temperature, blood pressure. Patient reported adverse events Safety laboratories: White blood cell count, Absolute neutrophil count, Hemoglobin, Platelets, Serum Creatinine, ALT, Alkaline phosphatase

Sponsors and collaborators

Lead sponsor

M.B.A. van Doorn

Other

Collaborators

  • Celgene

Registry information

Official study title

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

Acronym: SMASH

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 10, 2017
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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