Do you or a loved one have Hidradenitis Suppurativa (HS)?

If your HS has not responded to previous treatment, you may want to consider participating in the 22107 study.

What are clinical studies?

Clinical studies assess new ways to prevent, detect or treat many conditions, including HS. They provide valuable information about the safety and efficacy of potential new medications. Without them no new treatments could be developed.

Clinical studies follow standards and are closely regulated. Every study is reviewed and monitored closely to make sure that the rights of participants are protected, no unnecessary risks are involved and that the study answers important medical questions.

About the 22107 study

The 22107 study has been designed to assess the effectiveness and safety of izokibep, an investigational* drug in people with moderate to severe HS. Izokibep is a new drug which may reduce skin inflammation linked to HS, although it is not known if the study drug will help you.

You may be eligible** to take part in this study if you:

  • Are 18 – 75 years of age
  • Have a confirmed diagnosis of HS present on two different parts of your body
  • Have not responded to, are unable to take or have been intolerant to antibiotics, or if the HS has come back after treatment with antibiotics

*“Investigational” means the study drug is approved for use in clinical research but not yet approved for the treatment of HS.
**Full eligibility criteria apply

Treatment groups

Subjects in the 22107 study will be split into two groups; you will be randomly assigned into a group, but you and your study doctor will not know which one:

Group 1
(n= 125)
Placebo once a week from Week 0 to Week 15, then izokibep 160 mg once a week from Week 16 to Week 51.
Group 2
(n= 125)
Izokibep 160 mg once a week from Week 0 to Week 51.

A placebo is a substance that looks like the investigational drug but contains no active ingredients. Including placebo in a study helps researchers assess the safety and effectiveness of new investigational medicines. Neither you nor the study doctor will know whether you are receiving placebo or izokibep. Researchers will compare the results between the treatment groups to determine which is most appropriate for people with HS.

What will happen if I participate?

Screening for the study can take up to 4 weeks, during this time study doctors will ask you several medical questions and you will have health tests to determine if you qualify for this study. The screening period occurs before you get assigned to your treatment group.

If you are eligible to take part, you will return to the study center for up to 16 visits over the course of 59 weeks (51 weeks treatment period + 8 weeks follow up period) to receive the study drug and monitor your progress as well as your health. The study drug is administered as a subcutaneous (just below the skin) injection into your upper arm, upper thigh, or abdomen (belly). You may be trained how to administer yourself the study drug at home, so that you do not have to attend the clinic as often. Subjects may also choose to return to the clinic weekly for dosing. You will need to apply an antiseptic wash to your body areas affected with HS lesions every day during the treatment period. You will also need to complete a daily skin pain and pain-killer medication diary during the screening and treatment period.

Study visits

You will have numerous health checks including vital signs (temperature, pulse, breathing rate, and blood pressure), blood/urine tests, questionnaires about your health and assessments of your HS lesions. You will also receive the study drug, based on the schedule that your study doctor will provide.

The total study duration will be up to 63 weeks

  • Screening period of up to 28 days (4 weeks)
  • Study intervention period of up to 51 weeks
  • Follow-up period of 8 weeks

If you are interested in the study, you will be given an informed consent form to read and sign. This will provide you with all the study details, including potential risks and benefits, and you will be given a chance to ask any questions you might have before signing the form.

You would be a volunteer in this study and if during the study you change your mind, you are free to leave at any point. During the study the study drug will be provided to you free of charge.

Thank you for your interest in the 22107 study!

To learn more or to see if you or a loved one may qualify for the study, please contact: The Patient Engagement Team