Comparison of the Clinical Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Topical injection of Secukinmab
Other interventionTopical injection of Secukinmab
Subcutaneous injection of Secukinumab
DrugSubcutaneous injection of Secukinumab
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Topical injectionExperimental treatment 1 intervention
Group B: Subcutaneous injectionActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (Day 1) and Week 24Secondary outcomes
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.
Time frame
At Week4、8、12、16、20、242
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."
Time frame
Baseline (Day 1) and week4、8、12、16、20、243
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.
Time frame
Baseline (Day 1) and week4、8、12、16、20、244
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.
Time frame
Baseline (Day 1) and week4、8、12、16、20、24Other outcomes
1
Treatment-emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs) and other safety indicators
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.
Time frame
From baseline (Day 1) to week24Sponsors and contacts
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Source ClinicalTrials.gov
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