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
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).
- 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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.
Other Name: Otezla, CC-10004
Placebo Comparator: Placebo Oral Tablet
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
- Change of expression levels of inflammatory cytokine mRNA in HS lesional skin. [ Time Frame: t=16 weeks ]measurement by qPCR
- Change of expression levels of inflammatory cytokine protein in HS lesional skin. [ Time Frame: t=16 weeks ]measurement by ELISA
- Abscesses count [ Time Frame: t=0 weeks, t=4 weeks, t=16 weeks ]Total number of abscesses [A]
- Nodule count [ Time Frame: t=0 weeks, t=4 weeks, t=16 weeks ]Total number of inflammatory [N] and non-inflammatory nodules
- Fistula count [ Time Frame: t=0 weeks, t=4 weeks, t=16 weeks ]Total count of draining fistulas
- 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
- 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.
- 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;
- 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
- 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
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
|Erasmus University Medical Center|
|Principal Investigator:||Errol Prens||Erasmus Medical Center|