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A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE)

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Trial Profile

A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2024

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At a glance

  • Drugs Secukinumab (Primary)
  • Indications Hidradenitis suppurativa
  • Focus Registrational; Therapeutic Use
  • Acronyms SUNSHINE
  • Sponsors Novartis Healthcare; Novartis Pharma A.G.; Novartis Pharma KK; Novartis Pharmaceuticals

Most Recent Events

  • 22 May 2024 According to a Novartis media release, based on results from this trial and SUNRISE clinical trial, Health Canada has granted Cosentyx (secukinumab) with a Notice of Compliance (NOC), for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy.
  • 31 Oct 2023 According to a Novartis media release, based on analyses from the largest Phase III program in HS to date, SUNSHINE and SUNRISE study the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults
  • 01 Jun 2023 According to a Novartis media release, based on results from this trial, the European Commission (EC) has approved Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to conventional systemic HS therapy.

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