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

Phase 1

• Conditions: Hidradenitis Suppurativa (also known as Acne inversa); MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-005161-23-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-19
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

- 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