Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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.