CAIN457M2301E1 (SUN Extension) Secukinumab in hidradenitis suppurativa
Research type
Research Study
Full title
A Multicenter, Double-blind, Randomized Withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa
IRAS ID
261306
Contact name
Neila Benabadji
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-003230-17
Duration of Study in the UK
5 years, 4 months, 25 days
Research summary
The purpose of this clinical research extension study is to evaluate whether prolonged treatment with secukinumab in patients with moderate to severe hidradenitis suppurativa (HS), who took part in one of the two core studies (CAIN457M2301 SUNSHINE or CAIN457M2302 SUNRISE), will bring benefits to the patient and be safe. \nHS is a chronic,recurrent, and debilitating inflammatory skin condition that typically presents with deep,inflammatory, painful lesions in apocrine gland-bearing parts of the body. The most common areas affected are the axillae, the groin, and the anogenital region.\nThis extension study would be for up to another 4 years (Week 52 to Week 260).\nThe main objectives of this study are: \n•\tTo see if continuous use of secukinumab can help maintain improvement of HS. \n•\tTo see if it is safe for patients with HS to continue to receive secukinumab.\n•\tTo compare the effects of continuing secukinumab treatment with an interruption of the secukinumab treatment (using placebo instead).\nIn addition, it will determine if secukinumab works better if given once every 2 weeks or once every 4 weeks. The other objective of this study is to give the patients long term access to secukinumab.\nSecukinumab is a type of medicine called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and can bind to other specific proteins that your body produces. Secukinumab binds to and reduces the activity of a cytokine (a “messenger” protein in the body) called Interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and researchers believe that IL-17A contributes to symptoms of HS. So, it is believed that drugs that inhibit IL-17A, such as secukinumab, may help relieve these symptoms. \nSecukinumab/placebo will be administered to the patient via a pre-filled injection.\nThis extension study will be run at the same 12 hospital sites, who took part in the core studies. It is expected approximately 38 patients will take part in this extension study within the UK.\n
REC name
Wales REC 3
REC reference
19/WA/0365
Date of REC Opinion
22 Jan 2020
REC opinion
Further Information Favourable Opinion