Study to evaluate the safety and efficacy of Avacopan in subjects with moderate to severe hidraentis suppurativa
Brief description of study
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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
hidraentis suppurativa,dermatology
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
13 Jul 2023.
Study ID: 833016
