Hidradenitis Suppurativa (HS) is a skin condition that causes painful inflamed nodules or boils that rupture or ooze pus and leave scars on the skin. These lesions are likely to recur and may appear in a number of different locations on the body, typically around the groin and genital area, in armpits, around the buttocks and anus and underneath the breasts.1
How common is HS?
It is impossible to know precisely how many people have HS because, on average, people have symptoms for around 7 years before they are given a diagnosis.2 However, it is estimated to affect 1-4% of the worldwide population - a similar figure to psoriasis.1
Is participation in a clinical research study voluntary?
Yes, participation in any clinical research study is completely voluntary. If you decide to stop taking part at any time, it does not affect the medical care you would otherwise receive.
What are the investigational medications in the Ivy Study?
An investigational medication is a research drug that has not yet been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agencies for prescription by doctors for this particular disease. In the Ivy Study, three different investigational medications will be examined, and they each work in a different way within the body.
Will I receive one of the study medications?
Participants in the Ivy Study will be randomly assigned (i.e. by chance) to receive either one of the three investigational medications or a placebo (inactive drug). There is a 75% chance of receiving one of the study medications. Use of a placebo is normal practice in research studies in order to be sure that any benefits seen can be attributed to the study medication and would not just have happened anyway.
Will I know if I am taking one the study medications or a placebo?
No one taking part in the study, or any members of the study team, will know which medication you are allocated.
Can I request to be given one of the study medications?
No, you will be randomly assigned to either a study medication or placebo group.
Are there any risks involved in joining the study?
There are risks associated with taking any medication and the study medications are no different in this respect. You may experience side effects and there is no absolute guarantee that you will get any benefit from the study medication.
What are the benefits of taking part?
We hope you will view taking part in this study as a positive experience and an opportunity to potentially help improve the quality of life for others living with HS. You will receive study-related care at no cost and will be closely monitored by an expert medical team.
What happens if I change my mind about taking part?
You are completely free to leave the Ivy Study at any point if you decide that it is not right for you. The study doctor will explain about the treatment options available to you.
What happens to my personal information?
Information about your personal health will be kept private and confidential. If you decide to contact us, your details will be transferred to the Ivy Study team. A representative from the study team will contact you to determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA.
1. Dufour DN et al. Postgrad Med J 2014; 90:216-221.
2. Kimball A et al. N Engl J Med 2016; 375(5): 422-434.