Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College
Nanjing, Jiangsu, 210042, China
Location status: Recruiting
NCT Number: NCT06926192
This study aims to retrospectively analyze the efficacy and safety of secukinumab combined with surgery in treating moderate to severe HS in real-world clinical practice, providing clinical practioners with real-world evidence in HS treatment.
Interested in participating?
Request InfoUp to 80 year
All sexes
Observational
Nanjing, Jiangsu, 210042, China
Location status: Recruiting
Hidradenitis suppurativa (HS) is a chronic, recurrent, and disabling inflammatory disease that occurs in apocrine distribution sites such as the axilla, groin, and perianal region with a worldwide prevalence of approximately 1.5% -4.6%.The pathogenesis is excessive activation of the Th17 type immune response mediated by IL-17, IL-23, resulting in abnormal keratinization of hair follicles, obstruction of sebaceous ducts, and bacterial infection, culminating in abscesses, sinus tracts, and scarring.Patients with moderate to severe HS (Hurley stage II-III) often suffer from a severe decline in their quality of life due to recurrent infections, pain, and dysfunction, and their risk of depression is markedly elevated.Traditional treatments such as antibiotics, glucocorticoids, surgical debridement have limited efficacy, and the recurrence rate of surgery alone is as high as 50% -70%.In recent years, the use of biologic agents such as TNF-α inhibitors has dramatically improved HS outcomes, but 30% to 40% of patients still have an inadequate response to TNF-α inhibitors. Accumulating evidence suggests that the IL-17 pathway plays a key role in HS pathogenesis, that IL-17A expression is upregulated in the skin lesions of HS patients and positively correlates with disease severity. The efficacy and safety of secukinumab in combination with surgery remain unclear.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgery combined with secukinumab
Time frame: week 52
at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline)
Time frame: week 52
the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4)
Time frame: week 52
Change in number of inflammatory nodules
Time frame: week 52
Change in number of abscesses
Time frame: week 52
Change in number of sinus tracts
Time frame: week 52
NRS30 is defined as at least a 30% reduction from baseline and at least a 2-unit reduction in patient's global assessment of skin pain at worst
Time frame: week 52
Time to onset of action
Time frame: week 52
Duration of drug effect
Time frame: week 52
white blood cells, erythrocyte sedimentation rate, C-reactive protein
Time frame: week 52
Dermatology Life Quality Index
Time frame: week 52
Work Productivity and Activity Impairment
Time frame: week 52
Adverse effect and complications
Contact information is provided by the study sponsor or research team.
Peking Union Medical College
Other
Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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