Phase 3
Completed N=544
Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)
Source: ClinicalTrials.gov NCT03713632 ↗Enrolled (actual)
544
Serious AEs
8.1%
Results posted
Aug 2023
Primary outcomePrimary: Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) — 42.3; 46.1; 31.2 Percentage of Participants — p=0.0149
◆ Published Evidence
Highly cited
305citations · ~102 / year
Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials.
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 assessed the safety and tolerability of secukinumab.
Linked Publications (5)
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Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials.
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Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4): A post hoc analysis of the SUNSHINE and SUNRISE trials.
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New insights on hidradenitis suppurativa phenotypes and treatment response: An exploratory automated analysis of the SUNSHINE and SUNRISE trials.
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Assessing Long-Term Pain Reduction with Secukinumab in Moderate to Severe Hidradenitis Suppurativa: A Post Hoc Analysis of the SUNSHINE and SUNRISE Phase 3 Trials.
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Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) |
42.3; 46.1; 31.2 | 0.0149 sig |
| SECONDARY Percentage Change From Baseline in AN Count |
-39.3; -45.5; -22.4 | 0.0051 sig |
| SECONDARY Percentage of Participants With Hidradenitis Suppurativa (HS) Flares |
20.1; 15.6; 27.0 | 0.0732 |
| SECONDARY Percentage of Participants Achieving NRS30 |
38.6; 34.7; 22.4 | 0.0026 sig |
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 (NCT03713632) and the linked publication. 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. Informational only — not medical advice.