Double-Blind, Randomized, Placebo Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa (also known as Acne inversa)MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-005161-23-PT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 206
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- Evaluate the safety and efficacy of adalimumab when used after surgery, and <br>- Evaluate Patient Reported Outcomes (PRO) related to health status, HS-related symptoms, physical functioning, treatment satisfaction, and work/activity impairment. <br>- 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 Outcome Measures
Name Time Method 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 <br>- The percent change in surface area of the surgical site, and <br>- 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