Comparison of the Clinical Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS

NCT07261072 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-KY-067
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Secukinumab is currently approved in Europe, US and China for the treatment of moderate to severe HS as a biologic agent targeting IL-17A.Two phase III clinical trials (SUNSHINE and SUNRISE) showed that 300 mg s.c. every 2 weeks resulted in 42% to 45% of patients achieving a clinical response (HiSCR) to HS, and the efficacy was sustained through 52 weeks.However, we found in clinical practice that some HS patients present with localized lesions (small areas of involvement, affecting only 1-2 anatomic areas) that are resistant to conventional therapy, and have not yet fulfilled surgical indications, and the need for systemic biologic therapy is controversial.Such patients often experience inadequate response or slow onset of action when they receive secukinumab by routine subcutaneous injection - possibly related to inadequate drug concentration in the focal lesional area and limited local anti-inflammatory effects after systemic administration.In addition, side effects of conventional subcutaneous injection system are greater, and the application is limited in some patients, so it is necessary to explore more appropriate and safer drug delivery method for localized skin lesions.Localized HS, local injection of lesions may enhance anti-inflammatory effects while reducing systemic exposure by increasing drug concentrations at the lesion site.Therefore, exploring novel modes of administration of secukinumab has practical clinical implications based on clinical practice needs and the context of the previous literature.In summary, by exploring the efficacy and safety of local skin injection of secukinumab, this study may provide a new strategy for the treatment of limited HS with sufficient scientific rationale and significant potential benefits and manageable risks.

Conditions

Hidradenitis Suppurativa (Acne Inversa); Secukinumab; Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in International HS Severity Score System (IHS4)

  IHS4 score is calculated by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or higher signifies severe disease.

  Baseline (Day 1) and Week 24

Secondary Outcomes (7)

• Proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR)50

  At Week4、8、12、16、20、24

• Change from baseline in pain measured by Visual analog scale (VAS)

  Baseline (Day 1) and week4、8、12、16、20、24

• Change from baseline in Dermatology Life Quality Index (DLQI) Total Score

  Baseline (Day 1) and week4、8、12、16、20、24

• Change from baseline in white blood cell count (WBC)

  Baseline (Day 1) and week4、8、12、16、20、24

• Change from baseline in serum level of high-density C-reactive protein (hs-CRP)

  Baseline (Day 1) and week4、8、12、16、20、24

Other Outcomes (1)

• Treatment-emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs) and other safety indicators

  From baseline (Day 1) to week24

Study Arms (2)

Topical injection

EXPERIMENTAL

Other: Topical injection of Secukinmab

Subcutaneous injection

ACTIVE COMPARATOR

Drug: Subcutaneous injection of Secukinumab

Interventions

Topical injection of Secukinmab OTHER

Topical injection of Secukinmab

Topical injection

Subcutaneous injection of Secukinumab DRUG

Subcutaneous injection of Secukinumab

Subcutaneous injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet international diagnostic criteria for hidradenitis suppurativa
• Aged ≥ 18 years
• Disease duration ≥ 6 months and resistance to conventional therapy (no significant improvement for ≥ 3 months)
• Lesions were confined to a single anatomical area
• Voluntarily signed the informed consent form and was able to cooperate in all visits and examinations.

You may not qualify if:

• Hypersensitivity to any component of secukinumab injection
• With severe vital organ failure
• With active infection or malignancy (malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin and cured)
• Treatment with biologics, immunosuppressants, or systemic corticosteroids within the last 3 months
• Pregnant, nursing, or planning conception during the study
• Mental disorders or cognitive impairment that precludes understanding of study procedures
• Participating in another clinical study and are at risk of an interaction between the study drugs
• Other conditions assessed by the investigators as inappropriate for participation in the study

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College, Nanjing, Jiangsu 210042

Nanjing, Jiangsu, 210042, China

Location

Related Publications (11)

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  PMID: 24807602 RESULT

• Nguyen TV, Damiani G, Orenstein LAV, Hamzavi I, Jemec GB. Hidradenitis suppurativa: an update on epidemiology, phenotypes, diagnosis, pathogenesis, comorbidities and quality of life. J Eur Acad Dermatol Venereol. 2021 Jan;35(1):50-61. doi: 10.1111/jdv.16677. Epub 2020 Jul 16.

  PMID: 32460374 RESULT

• Zouboulis CC, Desai N, Emtestam L, Hunger RE, Ioannides D, Juhasz I, Lapins J, Matusiak L, Prens EP, Revuz J, Schneider-Burrus S, Szepietowski JC, van der Zee HH, Jemec GB. European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015 Apr;29(4):619-44. doi: 10.1111/jdv.12966. Epub 2015 Jan 30.

  PMID: 25640693 RESULT

• Zouboulis CC, Bechara FG, Fritz K, Goebeler M, Hetzer FH, Just E, Kirsten N, Kokolakis G, Kurzen H, Nikolakis G, Pinter A, Podda M, Rosinski K, Schneider-Burrus S, Taube KM, Volz T, Winkler T, Kristandt A, Presser D, Zouboulis VA. S2k guideline for the treatment of hidradenitis suppurativa / acne inversa - Short version. J Dtsch Dermatol Ges. 2024 Jun;22(6):868-889. doi: 10.1111/ddg.15412. Epub 2024 May 21.

  PMID: 38770982 RESULT

• Kimball AB, Jemec GBE, Alavi A, Reguiai Z, Gottlieb AB, Bechara FG, Paul C, Giamarellos Bourboulis EJ, Villani AP, Schwinn A, Rueff F, Pillay Ramaya L, Reich A, Lobo I, Sinclair R, Passeron T, Martorell A, Mendes-Bastos P, Kokolakis G, Becherel PA, Wozniak MB, Martinez AL, Wei X, Uhlmann L, Passera A, Keefe D, Martin R, Field C, Chen L, Vandemeulebroecke M, Ravichandran S, Muscianisi E. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023 Mar 4;401(10378):747-761. doi: 10.1016/S0140-6736(23)00022-3. Epub 2023 Feb 3.

  PMID: 36746171 RESULT

• Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, Prens EP, Schlessinger J, Zouboulis CC, van der Zee HH, Rosenfeld M, Mulani P, Gu Y, Paulson S, Okun M, Jemec GB. Adalimumab for the treatment of moderate to severe Hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012 Dec 18;157(12):846-55. doi: 10.7326/0003-4819-157-12-201212180-00004.

  PMID: 23247938 RESULT

• He F, Long FY, Zhang ZQ, Xia RY, Lu Y, Yin ZQ. Intramatricial injection of anti-interleukin-17A antibody for six patients with nail psoriasis. Clin Exp Dermatol. 2022 Feb;47(2):432-433. doi: 10.1111/ced.14933. Epub 2021 Oct 5. No abstract available.

  PMID: 34510518 RESULT

• Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.

  PMID: 27518661 RESULT

• Roccuzzo G, Repetto F, Giordano S, Sarda C, Comes A, Dapavo P, Quaglino P, Ribero S. Anti-IL17 Secukinumab in hidradenitis suppurativa: A long-term drug survival analysis. Exp Dermatol. 2024 Jul;33(7):e15140. doi: 10.1111/exd.15140.

  PMID: 39032087 RESULT

• Sabat R, Alavi A, Wolk K, Wortsman X, McGrath B, Garg A, Szepietowski JC. Hidradenitis suppurativa. Lancet. 2025 Feb 1;405(10476):420-438. doi: 10.1016/S0140-6736(24)02475-9. Epub 2025 Jan 22.

  PMID: 39862870 RESULT

• Goldburg SR, Strober BE, Payette MJ. Hidradenitis suppurativa: Epidemiology, clinical presentation, and pathogenesis. J Am Acad Dermatol. 2020 May;82(5):1045-1058. doi: 10.1016/j.jaad.2019.08.090. Epub 2019 Oct 9.

  PMID: 31604104 RESULT

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Junyou ZHENG, Dr

CONTACT

+86 9943909917; 19943909917@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)