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

Trial details

Who runs it

Peking Union Medical College

Trial code

NCT07261072

Record updated

3 December 2025

Original description

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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Treatment with biologics, immunosuppressants, or systemic corticosteroids within the last 3 months; Participating in another clinical study and are at risk of an interaction between the study drugs; 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); Mental disorders or cognitive impairment that precludes understanding of study procedures; Other conditions assessed by the investigators as inappropriate for participation in the study; Pregnant, nursing, or planning conception during the study.

ClinicalTrials.gov NCT07261072