CAIN457M2301 (SUNSHINE): Secukinumab in hidradenitis suppurativa
Research type
Research Study
Full title
A randomized, double-blind, multicenter 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
IRAS ID
254035
Contact name
Kave Shams
Contact email
Sponsor organisation
Novartis Pharmaceuticals
Eudract number
2018-002063-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 22 days
Research summary
Hidradenitis suppurativa (HS) is a chronic skin condition that features boils under the skin, most often in the areas where skin rubs together but can also appear on other parts of the body. The symptoms can include inflammation, pain, draining of liquids and scarring which may even restrict movement of arms and legs.
This clinical research study aims to find out if the drug secukinumab, also known as Cosentyx® is safe and has beneficial effects in people who have moderate to severe (HS). In addition, it will determine if secukinumab works better if given more frequently: once every 2 weeks instead of once a month. This study will test two secukinumab doses: 300 mg every 2 weeks and 300 mg every 4 weeks. These doses will be compared to placebo in the first part of the study, which lasts 16 weeks. After that time, everyone will receive secukinumab. A patients total participation in the study will be approximately 1 year, 3 months.
Secukinumab is a medicine which has not yet been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of people with HS. The secukinumab 300 mg every 4 weeks dose being tested in this study is the currently approved dosing regimen for other conditions in the UK. The secukinumab 300 mg every 2 weeks dosing being tested in this study is not currently approved. Approximately 27,000 patients enrolled in clinical studies have received at least one dose of Secukinumab to date.
About 471 patients will participate in this study at about 130 centres, across about 32 countries worldwide. In the UK, 6 centres will take part, who will collectively have about 24 patients taking part in the study.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0812
Date of REC Opinion
16 Jan 2019
REC opinion
Further Information Favourable Opinion