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

Study Identifier
M10-467
CT.gov Identifier
NCT00918255
EudraCT Identifier
2008-004587-38
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Hidradenitis Suppurativa (HS)
    • Study Drug
  • adalimumab
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol Summary

    This study will investigate how well adalimumab works in people with hidradenitis suppurativa

    (HS) in the short and long term.

    Study Locations

    Location
    Status
    Location
    Site Ref # / Investigator 19062
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Site Ref # / Investigator 18201
    Bakerfield, California, United States, 93309
    Status
    Not applicable
    Location
    Site Ref # / Investigator 18467
    Los Angeles, California, United States, 90045
    Status
    Not applicable
    Location
    Site Ref # / Investigator 18207
    San Diego, California, United States, 92103
    Status
    Not applicable
    Location
    Site Ref # / Investigator 18204
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Site Ref # / Investigator 18209
    Atlanta, Georgia, United States, 30327
    Status
    Not applicable
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