Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01635764
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Adalimumab pre-filled syringe, administered by subcutaneous injection

Study Details

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

Key Dates

Start date
Apr 30, 2012
Status verified
Jan 2018
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
508 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab Every Week
    Adalimumab 40 mg every week.

Primary Outcome Measure

Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit [ Time Frame: Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 ]

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