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

Abbott

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Biological: adalimumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918255

M10-467

2008-004587-38 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 3 patient groups, including a placebo group

Adalimumab 40 mg qwk

Experimental group

Description:

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.

Treatment:

Biological: adalimumab

Adalimumab 40 mg eow

Experimental group

Description:

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.

Treatment:

Biological: adalimumab

Placebo

Placebo Comparator group

Description:

Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.

Treatment:

Drug: Placebo