Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is 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 will also assess the safety and tolerability of secukinumab.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.