Secukinumab in Behcet’s
A Phase II, Multicentre, Randomised, Double Blind, Placebo Controlled Parallel Group Study, Followed By A 36 Week Active Treatment Phase To Evaluate The Efficacy And Safety Of Secukinumab In Patients With Non-Ocular Behçet's Syndrome
Liverpool University Hospital NHS Foundation Trust
This study is looking at a potential new treatment, Secukinumab for patients diagnosed with non-ocular Behçet's Syndrome. This is a phase II, proof of principle trial and wants to evaluate how safe and how effective Secukinumab might be for this group of patients.
We are aiming to recruit 64 patients over a 24 months period.
The patient population we would like to include into this study are patients who have previously not responded to first line therapy with topical steroid (mouth wash or skin cream), colchicine or azathioprine.
Patients will be randomly assigned to either the placebo or the study drug (Secukinumab) arm. Each patient will either receive 300mg subcutaneous (under the skin) injection of Secukinumab or matched placebo up to week 16. Injections will be self-administered once a week for four weeks (weeks 0, 1, 2, 3, 4), then once every four weeks at week 8 and 12. From week 16 we will not use placebo anymore and all patients will receive 300mg Secukinumab every 4 weeks up to and including week 48.
Patients will be required to attend 6 scheduled clinic visits and also have 6 follow-up telephone calls. The total duration of each patient's time in the study will be approximately 1 year.
The screening visit includes physical examination, medical history check, current medication and collection of demographic data such as gender and race. Blood samples will be collected (this will be routine clinical tests and will include HIV, hepatitis and tuberculosis testing) and urine samples. Other assessment will include blood pressure, respiration rate, temperature and an ECG test (which measures the electrical activity of the heart).Height and weight will also be measured.
Clinic visits days will include routine bloods and urine samples as well as genital and oral ulcer assessments and some questionnaires (quality of life, pain, disease activity and symptoms). Telephone consultation will be to check compliance and if any adverse events happened.
North West - Haydock Research Ethics Committee
Date of REC Opinion
13 May 2022
Further Information Favourable Opinion