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

NCT07261072 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College

Phase

Phase 4

Started

2025-12-01

Last updated

2025-12-03

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Topical injection of SecukinmabSubcutaneous injection of Secukinumab →

Topical injection of Secukinmab: Topical injection of Secukinmab

Subcutaneous injection of Secukinumab: Subcutaneous injection of Secukinumab

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

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

More Peking Union Medical College trials in China

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing Recruiting

Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway Starting soon

Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI) Recruiting

Effect of Hypophosphatemia on Neuro-excursion Efficiency During Mechanical Ventilator Weaning Recruiting

Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa Recruiting

Other trials for the same condition

Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa Recruiting

A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa Recruiting

Efficacy and Safety of Secukinumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa Recruiting

A Single-center, Prospective, Self-controlled, Observational Real-world Study of the Efficacy and Safety of Anti-IL-17A/F Monoclonal Antibody Combined With Non-ablative Dot Laser for the Treatment of Mild to Moderate Hidradenitis Suppurativa Starting soon

A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis Suppurativa Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07261072 on ClinicalTrials.gov ↗ ← All trials in China