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Hidradenitis Suppurativa (HS)Phase 4NCT07261072

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

A Phase 4 study testing Topical injection of Secukinmab and Subcutaneous injection of Secukinumab in people with Hidradenitis Suppurativa (HS) and Hidradenitis Suppurativa (Acne Inversa), run by Peking Union Medical College at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Topical injection of Secukinmab and Subcutaneous injection of Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Dec 2025to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Junyou ZHENG, Dr contact

+86 9943909917

19943909917@163.com

China1 site

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

    Nanjing, Jiangsu, 210042

    Junyou ZHENG, Dr, +86 19943909917, 19943909917@163.com

Other trials in China

About this study

Official title: Comparison of the Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS: A Prospective Exploratory Trial

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.

Read the detailed description

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent painful nodules, abscesses, sinus tracts, and scarring, with a global prevalence of about 1%, occurring in apocrine gland-rich areas such as the axillae and groin. Its pathogenesis is closely related to hair follicle obstruction, dysbacteriosis and immune disorders, in which IL-17A-mediated inflammatory pathways have been demonstrated to be the core driver - IL-17A levels are significantly increased in HS lesions, which can promote neutrophil infiltration and abscess formation.

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.The successful experience of topical injection of biologics in psoriasis provides an important reference for clinical practice, such as study of nail psoriasis showed that intralesional secukinumab significantly increased local drug concentrations with 73.2% improvement in nail lesions and good safety.This suggests that for 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.

Being tested
Topical injection of Secukinmab, Subcutaneous injection of Secukinumab
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical injection of SecukinmabOther

    Topical injection of Secukinmab

  • Subcutaneous injection of SecukinumabDrug

    Subcutaneous injection of Secukinumab

Study groups in NCT07261072
Study groupRoleWhat they receive
Topical injectionExperimentalNot described
Receives: Other: Topical injection of Secukinmab
Subcutaneous injectionActive comparatorNot described
Receives: Drug: Subcutaneous injection of Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 1) and Week 24

Secondary outcomes (7)

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

    HiSCR50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.

    Measured: At Week4、8、12、16、20、24

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

    Visual analog scale (VAS) is a simple, 1-dimensional scale that measures pain intensity, typically represented as a 10-cm horizontal line with anchors such as "no pain" and "worst possible pain."

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

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

    DLQI was a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The DLQI domains include symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The participant respond on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicated improvement in the Quality of Life.

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

  4. Change from baseline in white blood cell count (WBC)

    A white blood cell count test measures the number of white blood cells in a sample of blood.

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

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

    high-density C-reactive protein (hs-CRP), which is an acute phase protein (APP), is effective for evaluating the severity and degree of inflammation in patients with HS. A normal hs-CRP level is below 3.0 mg/L. A level between 3.1-10 mg/L is considered elevated. An hs-CRP level above 10 mg/ L is very high, more likely indicating an acute inflammatory event due to infection.

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

  6. Change from baseline in erythrocyte sedimentation rate (ESR)

    ESR is an indirect acute phase reactant reflecting plasma viscosity and the presence of APP, especially fibrinogen. ESR is a marker of HS disease activity. A normal range for ESR depends on your age and sex: Males younger than 50, less than 15 millimeters per hour (<15 mm/hr); males older than 50, <20mm/hr; females younger than 50, <20mm/hr; females older than 50, <30mm/hr

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

  7. Change from baseline in serum level of Interleukin-6 (IL-6)

    Level of serum IL-6 is considered as an inflammatory marker. The normal range of serum IL-6 lies between 0 to 1.8 pg/mL

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07261072
Sponsor's protocol ID
2025-KY-067
Status last verified
Nov 2025
First submitted
20 Nov 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Griffin N, Williams AB, Anderson S, Irving PM, Sanderson J, Desai N, Goh V. Hidradenitis suppurativa: MRI features in anogenital disease. Dis Colon Rectum. 2014 Jun;57(6):762-71. doi: 10.1097/DCR.0000000000000131.

    PubMed 24807602

  • 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.

    PubMed 32460374

  • 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.

    PubMed 25640693

  • 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.

    PubMed 38770982

  • 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.

    PubMed 36746171

  • 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.

    PubMed 23247938

  • 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.

    PubMed 34510518

  • 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.

    PubMed 27518661

  • 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.

    PubMed 39032087

  • 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.

    PubMed 39862870

  • 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.

    PubMed 31604104

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topical injection of Secukinmab and Subcutaneous injection of Secukinumab in people with Hidradenitis Suppurativa (HS) and Hidradenitis Suppurativa (Acne Inversa), run by Peking Union Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junyou ZHENG, Dr (+86 9943909917, 19943909917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in International HS Severity Score System (IHS4) (time frame: Baseline (Day 1) and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07261072, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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