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

December 2, 2025 updated by: Junyou ZHENG, Peking Union Medical College

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical injection
Other: Topical injection of Secukinmab
Topical injection of Secukinmab
Active Comparator: Subcutaneous injection
Drug: Subcutaneous injection of Secukinumab
Subcutaneous injection of Secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in International HS Severity Score System (IHS4)
Time Frame: Baseline (Day 1) and Week 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR)50
Time Frame: At Week4、8、12、16、20、24
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.
At Week4、8、12、16、20、24
Change from baseline in pain measured by Visual analog scale (VAS)
Time Frame: Baseline (Day 1) and week4、8、12、16、20、24
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."
Baseline (Day 1) and week4、8、12、16、20、24
Change from baseline in Dermatology Life Quality Index (DLQI) Total Score
Time Frame: Baseline (Day 1) and week4、8、12、16、20、24
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.
Baseline (Day 1) and week4、8、12、16、20、24
Change from baseline in white blood cell count (WBC)
Time Frame: Baseline (Day 1) and week4、8、12、16、20、24
A white blood cell count test measures the number of white blood cells in a sample of blood.
Baseline (Day 1) and week4、8、12、16、20、24
Change from baseline in serum level of high-density C-reactive protein (hs-CRP)
Time Frame: Baseline (Day 1) and week4、8、12、16、20、24
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.
Baseline (Day 1) and week4、8、12、16、20、24
Change from baseline in erythrocyte sedimentation rate (ESR)
Time Frame: Baseline (Day 1) and week4、8、12、16、20、24
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
Baseline (Day 1) and week4、8、12、16、20、24
Change from baseline in serum level of Interleukin-6 (IL-6)
Time Frame: Baseline (Day 1) and week4、8、12、16、20、24
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
Baseline (Day 1) and week4、8、12、16、20、24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs) and other safety indicators
Time Frame: From baseline (Day 1) to week24
A SAE is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. TEAEs are defined as those AEs that have a start date on or following the first dose of study treatment.
From baseline (Day 1) to week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KY-067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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