Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Biological: adalimumab
Drug: Placebo

Registration Number: NCT00918255

Lead Sponsor: Abbott

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 154

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab 40 mg qwk	adalimumab	Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Adalimumab 40 mg eow	adalimumab	Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Placebo	Placebo	Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Clinical Response at Week 16	Baseline, Week 16	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16	Baseline, Week 16	Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
Percentage of Participants Achieving Clinical Response at Week 2	Baseline, Week 2	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Percentage of Participants Achieving Clinical Response at Week 4	Baseline, Week 4	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Percentage of Participants Achieving Clinical Response at Week 8	Baseline, Week 8	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Percentage of Participants Achieving Clinical Response at Week 12	Baseline, Week 12	Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Change From Baseline in Modified Sartorius Scale at Week 16	Baseline, Week 16	The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Change From Baseline in Modified Sartorius Scale at Week 52	Baseline, Week 52	The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52	Baseline, Week 52	Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.

Trial Locations

Locations (26): Site Ref # / Investigator 18470
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Amsterdam, Netherlands
Site Ref # / Investigator 18209
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Atlanta, Georgia, United States
Site Ref # / Investigator 18683
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Copenhagen NV, Denmark
Site Ref # / Investigator 18463
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San Antonio, Texas, United States
Site Ref # / Investigator 18471
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Dessau, Germany
Site Ref # / Investigator 18202
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Skokie, Illinois, United States
Site Ref # / Investigator 19062
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Birmingham, Alabama, United States
Site Ref # / Investigator 18467
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Los Angeles, California, United States
Site Ref # / Investigator 18207
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San Diego, California, United States
Site Ref # / Investigator 18210
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Boston, Massachusetts, United States
Site Ref # / Investigator 18201
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Bakerfield, California, United States
Site Ref # / Investigator 19141
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New York, New York, United States
Site Ref # / Investigator 18211
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Evansville, Indiana, United States
Site Ref # / Investigator 18206
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Norfolk, Virginia, United States
Site Ref # / Investigator 18469
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Kiel, Germany
Site Ref # / Investigator 18684
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Roskilde, Denmark
Site Ref # / Investigator 18208
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New York, New York, United States
Site Ref # / Investigator 18203
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Boston, Massachusetts, United States
Site Ref # / Investigator 18981
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Hershey, Pennsylvania, United States
Site Ref # / Investigator 18204
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Miami, Florida, United States
Site Ref # / Investigator 19001
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Winston-Salem, North Carolina, United States
Site Ref # / Investigator 18466
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Omaha, Nebraska, United States
Site Ref # / Investigator 18461
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St Louis, Missouri, United States
Site Ref # / Investigator 18464
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Philadelphia, Pennsylvania, United States
Site Ref # / Investigator 19061
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Dallas, Texas, United States
Site Ref # / Investigator 18468
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Rotterdam, Netherlands