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

  • STATUS
    Recruiting
  • End date
    Aug 24, 2022
  • participants needed
    541
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 May 2021
abscess
hidradenitis
antiseptics
secukinumab

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.

Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 541 patients with moderate to severe HS. The study consists of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there will be an optional extension study. Adult males and females with moderate to severe HS will be included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing will be once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included The primary objective is to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; primary secondary objectives are to assess difference in proportion of patients with HS flares, and proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment. Key safety data will be collected, along with Patient Reported Outcomes

Details
Condition Hidradenitis Suppurativa, Acne Inversa
Treatment Placebo, Secukinumab
Clinical Study IdentifierNCT03713619
SponsorNovartis Pharmaceuticals
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hidradenitis Suppurativa or Acne Inversa?
Do you have any of these conditions: Acne Inversa or Hidradenitis Suppurativa?
Do you have any of these conditions: Hidradenitis Suppurativa or Acne Inversa?
Do you have any of these conditions: Acne Inversa or Hidradenitis Suppurativa?
Do you have any of these conditions: Acne Inversa or Hidradenitis Suppurativa?
Do you have any of these conditions: Hidradenitis Suppurativa or Acne Inversa?
Do you have any of these conditions: Hidradenitis Suppurativa or Acne Inversa?
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
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