Summary

for people ages 18-65 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

A Phase 4, Double-blind, Randomised, 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

Keywords

Hidradenitis Suppurativa (HS)Hidradenitis Suppurativaaxillainguinal regionHurley Stage I, II, or IIIadalimumabsecondary intentionabcess and inflammatory nodule (AN) countHidradenitis

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • Has a draining fistula count of greater than 20 at the Baseline visit
  • Requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
  • Requires surgical management prior to Week 13
  • Requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant

Locations

  • University of California Irvine /ID# 170054
    IrvineCalifornia92697-1385United States
  • Wallace Medical Group, Inc. /ID# 171289
    Beverly HillsCalifornia90211United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02808975
Phase
Phase 4
Study Type
Interventional
Last Updated