Primary objectives: To evaluate the expression of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): - of subjects receiving apremilast compared to subjects receiving placebo;- within both groups relative to…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The expression levels of inflammatory cytokine protein and mRNA in HS lesional
skin will be analysed atweek four (t=4) and week sixteen (t=16) and compared
between groups (apremilast and placebo). In addition, the expression levels at
t=16 for each separate group will be compared relative to baseline (t=0). The
proteins and genes of interest to be measured are IL-1β, IL-6, TNF-α, IL-10,
IL-12, IL-23, IL-17A and IL-17F , IFN-γ, IL-31. Exactly the same cytokines will
be measured using ELISA and qPCR.
Secondary outcome
The clinical efficacy will be measured using the following scoring systems:
• Individual inflammatory lesion count
• HS-Physician Global Assessment (HS-PGA)
• Hidradenitis Suppurativa Clinical Response (HiSCR)
The patient reported outcomes will be measured using the following scoring
sytems:
• NRS to assess pain, pruritus and patient disease global assessment score
• DLQI
Other study parameters
The following safety and tolerability parameters will be assessed:
• Vital signs: heart rate, blood pressure, temperature.
• Adverse events (every visit).
• Safety laboratories: WBC (white blood cell count), ANC (absolute neutrophil
count), Hemoglobin, Platelets, Serum Creatinine, ALT, Alkaline phosphatase.
Background summary
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 have shown
limited efficacy. The use of the selective immunosuppressant apremilast has not
yet been evaluated in HS. A phase II clinical trial on the clinical efficacy is
currently running in the USA. We 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 objective
Primary objectives: To evaluate the expression of inflammatory cytokines in HS
lesional skin at week four (t=4) and week sixteen (t=16):
- of subjects receiving apremilast compared to subjects receiving 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.
Study design
A double-blind randomised placebo-controlled trial; both interventional (Phase
II) and translational.
Intervention
Investigational product/treatment: Apemilast (Otezla)
Apremilast treatment for fifteen (n=15) subjects, and five (n=5) subjects
receiving placebo.
The duration of treatment with either apremilast or placebo per subject is 16
weeks.
Study burden and risks
Eligible patients will be recruited during routine clinical care. There is a
total of 7 site visits. The screening comprises a serum test and for women also
a pregnancy test. Twenty subjects will be allocated to treatment with either
apremilast (N=15; 75%) or placebo (N=5; 25%). Per subject a total number of
four blood samples and four biopsies will be obtained. Participants will be
asked to fill in the DLQI and NRS scores six times. Clinical photographs
(optional) will be taken on three occasions and the vital signs measured five
times. At every visit a short medical exam will be done and patients will be
asked about possible side effects.
Burg. s' Jacobplein 51
Rotterdam 3015 CA
NL
Burg. s' Jacobplein 51
Rotterdam 3015 CA
NL
Listed location countries
Age
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.
Exclusion criteria
Contraindication 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000859-27-NL |
| CCMO | NL57003.078.16 |