Study to evaluate the safety and efficacy of Avacopan in subjects with moderate to severe hidraentis suppurativa

  • STATUS
    Recruiting
  • participants needed
    10
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Updated on 19 February 2024

Summary

You are being invited to participate in a research study because you have hidradenitis suppurativa (HS), also called acne inversa. Avacopan is an investigational drug being studied to learn if it is safe and effective for the treatment for HS.

Description

Currently, the treatment for patients with HS includes local and systemic antibiotics, pain medication, and anti-TNF-a agents such as adalimumab. Acitretin is used in early stage disease. Other drugs such as cyclosporin, dapsone, and isotretinoin have been used with limited success. In HS disease, neutrophils, which are a type of white blood cells of the immune system, are attracted to the HS lesions. C5a is a protein of the immune system which is also located in the skin. C5a attracts neutrophils and binds to the C5a receptor (C5aR) of the neutrophils hereby contributing to the inflammation of the HS lesions. Avacopan binds and blocks the C5a receptor (or C5aR) of the neutrophils; this blockage means that the receptor can no longer be activated by C5a and the movement and binding of neutrophils to the site of inflammation through C5a is interrupted. 


This will be the first placebo-controlled clinical study of avacopan in hidradenitis suppurativa. Avacopan has been previously evaluated in placebo-controlled clinical studies involving 182 healthy adult subjects, and has been administered for up to 12 weeks in two placebo-controlled trials.  In an autoimmune disease, the immune system mistakes part of your body as foreign. It releases proteins called autoantibodies that attach healthy cells. For this purpose, the study will assess the safety and efficacy of avacopan. Safety is based on physical examinations and evaluation of the side effects and safety laboratory changes over the course of the study. The study will also evaluate the effect of avacopan on HS compared to a placebo treatment for the first part of the study. 

FAQ


Details
Condition hidraentis suppurativa,dermatology
Age 18years - 99years
Clinical Study IdentifierTX6257
Last Modified on19 February 2024

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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