Phase 3
N=544
This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT03713619 ↗Enrolled (actual)
544
Serious AEs
6.4%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) — 45.0; 41.8; 33.7 Percentage of participants — p=0.0070
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- secukinumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) |
45.0; 41.8; 33.7 | 0.0070 sig |
| SECONDARY Percentage Change From Baseline in AN50 Count at Week 16 |
-46.8; -42.4; -24.3 | <0.0001 sig |
| SECONDARY Percentage of Participants With Hidradenitis Suppurativa (HS) Flares |
15.4; 23.2; 29.0 | 0.0010 sig |
| SECONDARY Percentage of Participants Achieving NRS30 |
34.1; 32.2; 23.8 | 0.0248 sig |
Summary
The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study also assessed the safety and tolerability of secukinumab.
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Male and female patients ≥ 18 years of age.
- Diagnosis of HS ≥ 1 year prior to baseline.
- Patients with moderate to severe HS defined as:
- A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
- Inflammatory lesions should affect at least 2 distinct anatomic areas
- Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.
Exclusion Criteria
- Total fistulae count ≥ 20 at baseline.
- Any other active skin disease or condition that may interfere with assessment of HS.
- Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
- Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
- History of hypersensitivity to any of the study drug constituents.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT03713619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.