M15-574 SHARPS study, HS and Adalimubab with Surgery
Research type
Research Study
Full title
A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa
IRAS ID
206894
Contact name
Alison Miller
Contact email
Sponsor organisation
Abbvie Ltd
Eudract number
2015-005161-23
Duration of Study in the UK
2 years, 10 months, 18 days
Research summary
This study seeks to prove whether treatment of Hidradenitis Suppurativa (HS), with a drug called Adalimumab (Humira), is safe and effective, where the disease is severe enough that surgery is planned and performed to remove some of the affected area. So far no other drugs are approved to treat HS, and no studies investigated the use of adalimumab with surgery, in reducing disease progression. This study will be the first to evaluate this.
HS is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. Adalimumab is an anti-inflammatory drug which may reduce the inflammation and pain associated with the disease. It is injected in small volumes under the skin. The study will include people who have HS which is severe enough to need part of the affected area removing by surgery, and, in the opinion of the surgeon, that the two edges of skin would not be stitched together afterward for healing. This is known as ‘secondary intention’ healing. The participants will attend a hospital for dermatology and take either Adalimumab, or a placebo (water injection) for 24 weeks. The surgery will take place approximately 13 weeks after they start this treatment. The participants will be randomly assigned to Adalimumab or placebo in a 50:50 ratio, and neither they nor their doctors will know which. The success of the treatment will be assessed by doctors, by counting the numbers of lumps and abscesses at all parts of the body after 12 weeks of treatment, and also by measuring whether the area of skin that needed to be removed was smaller than the surgeon planned at the start of treatment.REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/1442
Date of REC Opinion
24 Oct 2016
REC opinion
Further Information Favourable Opinion