Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03049267
Other study ID # SMASH trial
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2, 2017
Est. completion date June 28, 2018

Study information

Verified date July 2018
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 28, 2018
Est. primary completion date December 6, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apremilast
Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.
Placebo Oral Tablet
Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.

Locations

Country Name City State
Netherlands Erasmus University Medical Center Rotterdam

Sponsors (2)

Lead Sponsor Collaborator
M.B.A. van Doorn Celgene

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of expression levels of inflammatory cytokine mRNA in HS lesional skin. measurement by qPCR t=16 weeks
Primary Change of expression levels of inflammatory cytokine protein in HS lesional skin. measurement by ELISA t=16 weeks
Secondary Abscesses count Total number of abscesses [A] t=0 weeks, t=4 weeks, t=16 weeks
Secondary Nodule count Total number of inflammatory [N] and non-inflammatory nodules t=0 weeks, t=4 weeks, t=16 weeks
Secondary Fistula count Total count of draining fistulas t=0 weeks, t=4 weeks, t=16 weeks
Secondary Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score Based on the HS lesion count t=0 weeks, t=4 weeks, t=16 weeks
Secondary Hidradenitis Suppurativa Clinical Response (HiSCR) 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. t=0 weeks, t=16 weeks
Secondary Numerical Rating Scale (NRS) To assess the patient reported outcome measures (PROMs) pain, pruritus and patient disease global assessment score; t=0 weeks, t=4 weeks, t=16 weeks
Secondary Dermatology Life Quality Index (DLQI) To assess the patient reported outcome measures (PROM) quality of life t=0 weeks, t=4 weeks, t=16 weeks
Secondary Incidence of Treatment-Emergent Adverse Events 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 Multiple time points between t=0 weeks and t=16 weeks
See also
  Status Clinical Trial Phase
Completed NCT02904902 - Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa Phase 3
Completed NCT03628924 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Not yet recruiting NCT05531747 - Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa N/A
Recruiting NCT06028230 - A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Completed NCT03275870 - Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa Phase 1/Phase 2
Completed NCT03248531 - A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. Phase 2
Withdrawn NCT04100083 - Spironolactone for Hidradenitis Suppurativa Phase 4
Completed NCT00329823 - Etanercept in Hidradenitis Suppurativa Phase 2
Recruiting NCT05710393 - Hidradenitis - an Analysis of Genetic Traits and Linkages in Families
Completed NCT04019041 - A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa Phase 2
Completed NCT05286567 - A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa. Phase 1
Withdrawn NCT03929835 - Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Phase 2
Terminated NCT04325607 - Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa N/A
Terminated NCT03238469 - Microwave Ablation in Mild Axillary Hidradenitis Suppurativa N/A
Completed NCT04449354 - HidraWear AX HS Study N/A
Recruiting NCT06123429 - Mindfulness in Hidradenitis Suppurativa N/A
Recruiting NCT05934825 - Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa Phase 1/Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06046729 - A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2