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Do you have hidradenitis suppurativa (HS)?

Hidradenitis suppurativa is a skin condition that causes painful bumps and abscesses under your skin in the hair roots and near sweat glands. The bumps can become infected and cause scarring. HS is also known as acne inversa or Verneuil’s Disease.

Researchers are testing a new investigational treatment called tibulizumab in a study to see if it can reduce bumps and abscesses in people who are affected with this condition.

Participants aged 18 to 70 years with hidradenitis suppurativa, are being invited to participate in this study.

If you participate in this study, you will be provided with all study medication, examinations, and medical care related to the study free of charge.

If eligible to take part, your participation may support the development of this investigational treatment for individuals with HS.

 

Study purpose:

This study is being done to evaluate the safety, effectiveness, and tolerability of the study drug. The study drug is an injectable (like a shot) drug known as tibulizumab or placebo (dummy drug).

Study participation will last approximately 45 weeks and includes up to 13 visits in total. The study includes-

  • A screening period (up to 30 days). 
  • A 16-week randomized treatment period (during which participants will be assigned to receive 1 of the 2 doses of tibulizumab being tested, or placebo randomly, like flipping a coin). 
  • A 16-week open-label treatment period for eligible participants (during which all participants will receive the active investigational treatment, tibulizumab). 
  • A safety follow-up visit (8 weeks later).  

Návštěvy
Celkem
Délka
Postupy
Délka studie
Celkem
13 visits over approximately 45 weeks
Délka
2 to 4 hours per visit
Postupy
Blood pressure measurement, ECGs, safety blood samples and samples to measure drug and proteins associated with HS in the blood. Questionnaires related to HS.
Délka studie
Up to 30 days of screening period, 32 weeks of treatment, and approximately 8 weeks of follow up period, about 45 weeks
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