Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 3:30 PM
Study NCT ID:
NCT06926192
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HiSCR', 'timeFrame': 'week 52', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'IHS4', 'timeFrame': 'week 52', 'description': 'the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4)'}, {'measure': 'Change in number of inflammatory nodules', 'timeFrame': 'week 52', 'description': 'Change in number of inflammatory nodules'}, {'measure': 'Change in number of abscesses', 'timeFrame': 'week 52', 'description': 'Change in number of abscesses'}, {'measure': 'Change in number of sinus tracts', 'timeFrame': 'week 52', 'description': 'Change in number of sinus tracts'}, {'measure': 'HS related skin pain (NRS30)', 'timeFrame': 'week 52', 'description': "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"}, {'measure': 'Time to onset of action', 'timeFrame': 'week 52', 'description': 'Time to onset of action'}, {'measure': 'Duration of drug effect', 'timeFrame': 'week 52', 'description': 'Duration of drug effect'}, {'measure': 'Changes in inflammatory markers', 'timeFrame': 'week 52', 'description': 'white blood cells, erythrocyte sedimentation rate, C-reactive protein'}, {'measure': 'DLQI', 'timeFrame': 'week 52', 'description': 'Dermatology Life Quality Index'}, {'measure': 'WPAI', 'timeFrame': 'week 52', 'description': 'Work Productivity and Activity Impairment'}, {'measure': 'Adverse effect and complications', 'timeFrame': 'week 52', 'description': 'Adverse effect and complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa (HS)', 'Hidradenitis Suppurativa (Acne Inversa)', 'Secukinumab']}, 'referencesModule': {'references': [{'pmid': '40023624', 'type': 'BACKGROUND', 'citation': 'Fang V, Gupta R, Micheletti RG. Managing Hidradenitis Suppurativa with Biologics and Small Molecule Inhibitors. Dermatol Clin. 2025 Apr;43(2):231-245. doi: 10.1016/j.det.2024.12.008. Epub 2025 Jan 21.'}, {'pmid': '40062409', 'type': 'BACKGROUND', 'citation': 'Calabrese L, Cartocci A, Rubegni P, French LE, Kendziora B. Efficacy and safety of biologics for hidradenitis suppurativa: A network meta-analysis of phase III trials. J Eur Acad Dermatol Venereol. 2025 Mar 10. doi: 10.1111/jdv.20617. Online ahead of print.'}, {'pmid': '28027202', 'type': 'BACKGROUND', 'citation': 'Kohorst JJ, Baum CL, Otley CC, Roenigk RK, Pemberton JH, Dozois EJ, Tran NV, Davis MD. Patient Satisfaction and Quality of Life Following Surgery for Hidradenitis Suppurativa. Dermatol Surg. 2017 Jan;43(1):125-133. doi: 10.1097/DSS.0000000000000942.'}, {'pmid': '39941581', 'type': 'BACKGROUND', 'citation': 'Caliezi A, Rabufetti A, Hunger R, Wolf R, Seyed Jafari SM. Impact of Hidradenitis Suppurativa on Sexual Quality of Life. J Clin Med. 2025 Jan 30;14(3):910. doi: 10.3390/jcm14030910.'}, {'pmid': '38146560', 'type': 'BACKGROUND', 'citation': 'Agnese ER, Tariche N, Sharma A, Gulati R. The Pathogenesis and Treatment of Hidradenitis Suppurativa. Cureus. 2023 Nov 25;15(11):e49390. doi: 10.7759/cureus.49390. eCollection 2023 Nov.'}, {'pmid': '22236226', 'type': 'BACKGROUND', 'citation': 'Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old with moderate-severe (Hurley II-III) HS\n2. The diagnosis of HS was confirmed by histopathological examination in the Department of Pathology of our hospital\n3. Patients with HS who received secukinumab combined with surgery in the Department of Dermatologic Surgery of our hospital\n4. Patients with complete clinical data followed up for at least 1 year\n\nExclusion Criteria:\n\n1. Patients lost to follow-up\n2. Patients with less than one year of follow-up\n3. Patients who received additional adjuvant therapy during the follow-up period'}, 'identificationModule': {'nctId': 'NCT06926192', 'briefTitle': 'Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College'}, 'officialTitle': 'Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: An Open-label Cohort Study in Real Clinical Practice', 'orgStudyIdInfo': {'id': '2025-KY-016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Moderate to severe hidradenitis suppurativa', 'interventionNames': ['Combination Product: Surgery combined with secukinumab']}], 'interventions': [{'name': 'Surgery combined with secukinumab', 'type': 'COMBINATION_PRODUCT', 'description': 'Surgery combined with secukinumab', 'armGroupLabels': ['Moderate to severe hidradenitis suppurativa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210042', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youjun ZHENG', 'role': 'CONTACT', 'email': '19943909917@163.com', 'phone': '+61 19943909917'}], 'facility': 'Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Youjun ZHENG', 'role': 'CONTACT', 'email': '19943909917@163.com', 'phone': '1+86 9943909917'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Junyou ZHENG', 'investigatorAffiliation': 'Peking Union Medical College'}}}}