Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically

• Status: Completed
• Trial end date: 2019-10-16
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit

• Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus

• either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and

• with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III

• Participant 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:

• Participant has a draining fistula count of greater than 20 at the Baseline visit

• Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site

• Participant requires surgical management prior to Week 13

• Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant