HS OBTAIN Research Study Information
YOU CAN APPLY IF YOU:
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Are between 18 and 70 years old
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Have had HS for at least 1 year
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Have HS in 2 different areas on your body, one of which must be Hurley Stage 2 or 3
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Didn’t respond to or couldn’t tolerate antibiotics
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Have either not been on any TNF therapy OR have been on TNF therapy for at least 12 weeks in the past which wasn't effective or worked for a period of time and then no longer worked
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YOU CAN'T APPLY IF YOU:
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Have more than 20 draining tunnels/fistulas
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Have had elective surgical treatment in the last 4 weeks for HS or are planning surgery during the treatment period
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Are currently or have recently had a serious infection
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Have inflammatory conditions, other than HS (including, but not limited to, systemic lupus, sclerosis, myostitis, rheumatoid arthritis, IBD, MS, sarcoidosis, etc.)
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Have moderate to severe congestive heart failure
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Presence of active suicidal ideation or suicidal ideation in the past 6 months
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Are pregnant, breastfeeding, or plan on becoming pregnant during the treatment period
There may be other information that the doctor will use to decide if you’re eligible to join; the above are the main study criteria.
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HOW IT WORKS:
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The screening period takes up to 4 weeks to determine eligibility
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Once approved to participate
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PART A - You will be given either the study drug or placebo drug for 16 weeks which includes 9 visits to the clinical trial site​​
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PART B - ALL participants will be given the study drug for 12 weeks with 6 site visits (some may be at home
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PART C - Follow up for 8 weeks with 1 visit to the site
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HERE'S WHAT'S REQUIRED OF YOU:
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You must be willing to have an injection in your abdomen every 2 weeks and an exam at each visit.
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You must be willing to attend ALL study visits during the trial.
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You will have multiple forms that have to be completed (# of forms vary per visit) which may be of a sensitive nature and ask about the impact of your HS on your life and mental health issues.
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You will be required to complete a daily diary.
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You must use highly effective forms of birth control during the study.
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You will not be allowed to take any opioids during the study (NSAIDs, acetaminophen, and tramadol are OK).
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You must keep a log of all medications including NSAIDs (Tylenol, Advil, Aleve or equivalent) with the dates, times, and reasons for taking.
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LEARN MORE AND APPLY HERE
OR VISIT SANOFISTUDIES.COM KEYWORDS: HS OBTAIN