Clinical trial NCT00918255: Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Official title: A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Adalimumab
Nodule
Abscess
Fistula
Physicians Global Assessment
Hurley Stage
Sartorius Scale
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Response at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving Clinical Response at Week 2
timeFrame: Baseline, Week 2
measure: Percentage of Participants Achieving Clinical Response at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants Achieving Clinical Response at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants Achieving Clinical Response at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Modified Sartorius Scale at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Modified Sartorius Scale at Week 52
timeFrame: Baseline, Week 52
measure: Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Ref # / Investigator 19062
state: Alabama
city: Bakerfield
country: United States
facility: Site Ref # / Investigator 18201
state: California
city: Los Angeles
country: United States
facility: Site Ref # / Investigator 18467
state: California
city: San Diego
country: United States
facility: Site Ref # / Investigator 18207
state: California
city: Miami
country: United States
facility: Site Ref # / Investigator 18204
state: Florida
city: Atlanta
country: United States
facility: Site Ref # / Investigator 18209
state: Georgia
city: Skokie
country: United States
facility: Site Ref # / Investigator 18202
state: Illinois
city: Evansville
country: United States
facility: Site Ref # / Investigator 18211
state: Indiana
city: Boston
country: United States
facility: Site Ref # / Investigator 18203
state: Massachusetts
city: Boston
country: United States
facility: Site Ref # / Investigator 18210
state: Massachusetts
city: St Louis
country: United States
facility: Site Ref # / Investigator 18461
state: Missouri
city: Omaha
country: United States
facility: Site Ref # / Investigator 18466
state: Nebraska
city: New York
country: United States
facility: Site Ref # / Investigator 19141
state: New York
city: New York
country: United States
facility: Site Ref # / Investigator 18208
state: New York
city: Winston-Salem
country: United States
facility: Site Ref # / Investigator 19001
state: North Carolina
city: Hershey
country: United States
facility: Site Ref # / Investigator 18981
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Ref # / Investigator 18464
state: Pennsylvania
city: Dallas
country: United States
facility: Site Ref # / Investigator 19061
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 18463
state: Texas
city: Norfolk
country: United States
facility: Site Ref # / Investigator 18206
state: Virginia
city: Copenhagen NV
country: Denmark
facility: Site Ref # / Investigator 18683
city: Roskilde
country: Denmark
facility: Site Ref # / Investigator 18684
city: Dessau
country: Germany
facility: Site Ref # / Investigator 18471
city: Kiel
country: Germany
facility: Site Ref # / Investigator 18469
city: Amsterdam
country: Netherlands
facility: Site Ref # / Investigator 18470
city: Rotterdam
country: Netherlands
facility: Site Ref # / Investigator 18468
Study officials:
affiliation: Abbott
name: Martin Okun, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
citation: Scheinfeld N, Sundaram M, Teixeira H, Gu Y, Okun M. Reduction in pain scores and improvement in depressive symptoms in patients with hidradenitis suppurativa treated with adalimumab in a phase 2, randomized, placebo-controlled trial. Dermatol Online J. 2016 Mar 16;22(3):13030/qt38x5922j.
citation: Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, Prens EP, Schlessinger J, Zouboulis CC, van der Zee HH, Rosenfeld M, Mulani P, Gu Y, Paulson S, Okun M, Jemec GB. Adalimumab for the treatment of moderate to severe Hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012 Dec 18;157(12):846-55. doi: 10.7326/0003-4819-157-12-201212180-00004.