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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT03713619

Run by

Novartis Pharmaceuticals

People needed

544

Starts

2019-01-31

Expected to finish

2022-07-26

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Rogers, Arkansas, United States
• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Glenview, Illinois, United States
• Novartis Investigative Site — West Dundee, Illinois, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — New Brighton, Minnesota, United States
• Novartis Investigative Site — Saint Joseph, Missouri, United States
• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Fairborn, Ohio, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Goodlettsville, Tennessee, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Ciudad Autonoma de Bs As, Buenos Aires, Argentina
• Novartis Investigative Site — La Plata, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Phillip, Australian Capital Territory, Australia
• Novartis Investigative Site — Benowa, Queensland, Australia
• Novartis Investigative Site — East Melbourne, Victoria, Australia
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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