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

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ClinicalTrials.gov Identifier: NCT03049267
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.B.A. van Doorn, Erasmus Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Apremilast Drug: Placebo Oral Tablet Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Apremilast
N=15
Drug: Apremilast
Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.
Other Name: Otezla, CC-10004

Placebo Comparator: Placebo Oral Tablet
N=5
Drug: Placebo Oral Tablet
Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.
Other Name: Placebo comparator




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049267


Locations
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Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
M.B.A. van Doorn
Celgene
Investigators
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Principal Investigator: Errol Prens Erasmus Medical Center

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Responsible Party: M.B.A. van Doorn, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03049267     History of Changes
Other Study ID Numbers: SMASH trial
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by M.B.A. van Doorn, Erasmus Medical Center:
acne inversa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Thalidomide
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents