Hidradenitis Suppurativa (also known as Acne inversa) MedDRA version: 19.1 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 197 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
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 |
|---|---|
| Main Objective: Assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical candidates.; Secondary Objective: - Assess the impact of adalimumab on the planned HS surgical site before surgery - Evaluate the safety and efficacy of adalimumab when used after surgery, and - Evaluate Patient Reported Outcomes (PRO) related to health status, HS-related symptoms, physical functioning, treatment satisfaction, and work/activity impairment. - Evaluate the pharmacokinetics (PK) and immunogenicity of adalimumab. ;Primary end point(s): - The primary efficacy variable is the proportion of subjects achieving HiSCR (Hidradenitis Suppurativa Clinical Response). HiSCR is defined as at least a 50% reduction in the AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of subjects achieving HiSCR-es (defined as the HiSCR excluding the HS surgical site) at Weeks 12 and 24 - The percent change in surface area of the surgical site, and - The proportion of subjects at Week 12 that require less extensive surgical than the surgical plan (determined at Baseline) or no surgery. ;Timepoint(s) of evaluation of this end point: Weeks 12 and 24 | — |
Countries
Argentina, Belgium, Brazil, Canada, Colombia, Czech Republic, Denmark, European Union, Ireland, Israel, Mexico, Netherlands, Norway, Portugal, Russian Federation, Saudi Arabia, Sweden, Turkey, United Kingdom
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed