Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
This study will investigate how well adalimumab works in people with hidradenitis suppurativa
 (HS) in the short and long term.
This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2
 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0
 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16
 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as
 stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every
 other week (eow), or matching placebo during Period 1. During Period 2, participants receive
 open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28
 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or
 worse (score of greater than or equal to 3). The primary objective of the study is to
 determine the clinical efficacy and safety of participants with moderate to severe chronic
 hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to
 evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36
 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that
 is largely based on the presence and extent of abscess formation accompanied by scarring and
 sinus tracts. Hurley Stages are I [abscess formation without scarring and sinus tracts], II
 [widely separated recurrent abscesses with scarring and sinus tracts], and III [multiple
 interconnected abscesses and sinus tracts across entire area]. Randomization in this study
 was performed using stratification by Hurley Stage [III versus (I or II).) At the present
 time, Period 1 double-blind data only is provided; additional information will be provided
 when analysis of open-label Period 2 is completed.
Inclusion Criteria:

 -  Adults with stable, moderate to severe hidradenitis suppurativa

 -  Negative Chest X-ray and PPD test at Screening. If participant has had a past
 ulcerative reaction to PPD placement and/or chest X-ray consistent with prior
 tuberculosis exposure, the participant must initiate, or have documented completion
 of, a course of anti-tuberculosis therapy.

 -  Ability to administer subcutaneous injections

 -  General good health otherwise

 Exclusion Criteria:

 -  Prior anti-TNF therapy

 -  Unstable antibiotic therapy for HS

 -  Required medication washouts for other HS treatments

 -  Prior exposure to Tysabri® (natalizumab);

 -  Recent infection requiring treatment

 -  Significant medical events or conditions that may put patients at risk for
 participation

 -  Female subjects who are pregnant or breast-feeding or considering becoming pregnant
 during the study;

 -  History of cancer, except successfully treated skin cancer

 -  Recent history of drug or alcohol abuse