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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hidradenitis Suppurativa

Intervention: adalimumab (Biological); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Martin Okun, MD, PhD, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

Official title: A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants Achieving Clinical Response at Week 16

Secondary outcome:

Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16

Percentage of Participants Achieving Clinical Response at Week 2

Percentage of Participants Achieving Clinical Response at Week 4

Percentage of Participants Achieving Clinical Response at Week 8

Percentage of Participants Achieving Clinical Response at Week 12

Change From Baseline in Modified Sartorius Scale at Week 16

Change From Baseline in Modified Sartorius Scale at Week 52

Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Site Ref # / Investigator 18683, Copenhagen NV 2400, Denmark

Site Ref # / Investigator 18684, Roskilde 4000, Denmark

Site Ref # / Investigator 18471, Dessau 06847, Germany

Site Ref # / Investigator 18469, Kiel 24105, Germany

Site Ref # / Investigator 18470, Amsterdam 1105 AZ, Netherlands

Site Ref # / Investigator 18468, Rotterdam 3015 CA, Netherlands

Site Ref # / Investigator 19062, Birmingham, Alabama 35205, United States

Site Ref # / Investigator 18201, Bakerfield, California 93309, United States

Site Ref # / Investigator 18467, Los Angeles, California 90045, United States

Site Ref # / Investigator 18207, San Diego, California 92103, United States

Site Ref # / Investigator 18204, Miami, Florida 33136, United States

Site Ref # / Investigator 18209, Atlanta, Georgia 30327, United States

Site Ref # / Investigator 18202, Skokie, Illinois 60077, United States

Site Ref # / Investigator 18211, Evansville, Indiana 47714, United States

Site Ref # / Investigator 18203, Boston, Massachusetts 02111, United States

Site Ref # / Investigator 18210, Boston, Massachusetts 02114, United States

Site Ref # / Investigator 18461, St Louis, Missouri 63104, United States

Site Ref # / Investigator 18466, Omaha, Nebraska 68144, United States

Site Ref # / Investigator 18208, New York, New York 10019, United States

Site Ref # / Investigator 19141, New York, New York 10016, United States

Site Ref # / Investigator 19001, Winston-Salem, North Carolina 27103, United States

Site Ref # / Investigator 18981, Hershey, Pennsylvania 17033, United States

Site Ref # / Investigator 18464, Philadelphia, Pennsylvania 19104, United States

Site Ref # / Investigator 19061, Dallas, Texas 75246-1613, United States

Site Ref # / Investigator 18463, San Antonio, Texas 78258, United States

Site Ref # / Investigator 18206, Norfolk, Virginia 23507, United States

Additional Information

Starting date: April 2009
Last updated: April 14, 2011

Page last updated: August 23, 2015

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