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YOU CAN APPLY IF YOU:

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• Are between 18 and 75 years old

• Have had HS for at least 12 months

• Have HS in 2 different areas on your body

• Didn’t respond to or couldn’t tolerate antibiotics

• Have a total abscess count and inflamed nodule count) of more than 5 at both visits (see more below)

• Must agree to use a topical antiseptic wash on your affected areas daily

 

YOU CAN'T APPLY IF YOU:

 

• Have more than 20 draining tunnels/fistulas

• Have had surgical treatment in the last 4 weeks for HS

• Are currently or recently fighting an acute infection 

• Have a serious or recurring infection within the last 12 weeks

• Have HIV, hepatitis  or C infection, or active TB infection

• Are on opioids for pain within 14 days prior to visit 2 (see more below)

• Anticipate the use of opioids during the study

• Are not willing to receive subcutaneous injections (injections into the skin)

• Are pregnant or breastfeeding or plan on becoming pregnant

 

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.

 

HOW IT WORKS:

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You will have 2 visits to get started.  

 

Visit #1 is a screening visit where you talk about what is expected, sign consent forms, and talk through the trial with the site. There will be a physical examination including checking and counting lesions. They will take any blood samples and urine samples needed in order to ensure you’re healthy enough to participate in the trial.

 

Visit #2 is the randomization visit where you will start your study treatment or the placebo.  This is decided by computer and neither you or the trial site will know if you’ve been given the investigational medication or the placebo medication.  A placebo is not the actual medication, but may be a saline solution.  The information gathered from the placebo group is still very important to the study. 

 

You will visit the clinical trial site every 2 weeks during the treatment period (which is 52 weeks in total).  You will have an injection at each of those visits in the abdomen as well as an examination.

 

You will be monitored for 30 minutes after each injection to ensure there are no adverse effects. 

 

After16 weeks, EVERYONE will receive the medication, including those who had the placebo originally. 

 

For the next 36 weeks, ALL participants will have the actual trial medication and will have visits to the site every 2 weeks.

 

Once the 52 weeks are up, there will be a 12 week follow-up period where you go every 4 weeks to the clinical trial site. 

 

HERE'S WHAT'S REQUIRED OF YOU:

 

• You must be willing to have an injection in your abdomen every 2 weeks and an exam at each visit.

• You must be willing to attend ALL study visits every 2 weeks during the trial.

• You will have up to 7 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.

• You will be required to complete a daily diary.

• You must use highly effective forms of birth control during the study.

• You will be monitored for 30 minutes after each injection.

• You must use an approved antiseptic wash daily during the trial.

• You will not be allowed to take any opioids during the study (NSAIDs, acetaminophen, and tramadol are OK).

• You will not be allowed to take Humira or other immunomodulatory agents.

• You must keep a log of all medications including NSAIDs (Tylenol, Advil, Aleve or equivalent) with the dates, times, and reasons for taking.

 

STOPPING MEDICATION PRIOR TO TRIAL:

 

If you’re using TOPICAL antibiotics, you must stop using 14 days prior to Visit #2.

 

If you’re using ORAL antibiotics, you must stop using 28 days prior to Visit #2.  Please speak with your physician prior to stopping any medication. 

 

If you wish to continue ORAL antibiotics during the course of the trial:

 

• It must be a tetracycline medication.

• You must be on a stable dose for 4 weeks.

• You must remain on the same dose for the whole study.

If you’re interested in finding out if you’re eligible to participate or if there's a clinical trial site near you,  please complete the form here and we'll get back to you!!