Hidradenitis Suppurativa
Conditions
Interventions
Subjects receive subcutaneous injections of adalimumab for the duration of 23
weeks in addition to the standard of care for HS. In this case, patients
undergo surgery (excision of HS site) as part o
fasting), 5 skin-swabs, obtaining
skin-biopsies (total of 6) and maintaining and analysis of leftover surgical
tissue. The patient can choose which materials are collected for this optional
study.
Sponsors
AbbVie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male and female subjects between the ages of 18 and 65, inclusive;;- Subject must have skin lesions that are diagnostic of HS for at least 1 year (365 days) prior to the Baseline visit;- Subject must have at least 3 distinct anatomical regions involved with inflammatory ( also termed *active*) HS lesions; including;(a) either an axilla or unilateral inguinal region (limited to the inguinal-crural fold and adjacent areas) that requires excisional surgery (hereinafter designated the *HS surgical site*), and ;(b) with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region; hereinafter designated the 'HS non-surgical sites) rated as Hurley Stage II or III;- Subject must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites;- The HS surgical site must contain at least one active HS lesion;- The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon
Exclusion criteria
Exclusion criteria: - Subject has a draining fistula count of greater than 20 at the Baseline visit;- Subject requires surgery at any anatomical site other than an unilateral axilla or inguinal region site ;- Subject requires surgical management prior to Week 13, based on the designated surgeon's assessment;- Subject requires, based on designated surgeon's assessment, excisional surgery with primary closure, partial surgical reduction of the excised area with surgical suture, or reconstruction techniques as the method of closure being most beneficial for the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the proportion of subjects achieving HiSCR (Hidradenitis Supprative Clinial Response) at Week 12. HiSCR is defined as at least a 50% reduction in the HS abscess plus inflammatory nodule [AN] count with no increase in abscess count and no increase in draining fistula count relative to Baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include the proportion of subjects achieving HiSCR-es (defined as the HiSCR excluding the HS surgical site) at Weeks 12 and 24, the change in surface area of the HS surgical site at Week 12, and the proportion of subjects at Week 12 that require less extensive surgical than the surgical plan (determined at Baseline) or no surgery. | — |
Countries
Netherlands
Outcome results
None listed