Efficacy & safety of S95011 in primary sjogrens syndrome patients
Research type
Research Study
Full title
A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study.
IRAS ID
284245
Contact name
Benjamin FISHER
Contact email
Sponsor organisation
Servier Research & Development Ltd
Eudract number
2020-001526-59
Duration of Study in the UK
1 years, 9 months, 26 days
Research summary
Phase IIa proof of concept study to evaluate preliminary efficacy and safety of S95011 in patients with primary Sjögren’s Syndrome (pSS). pSS is characterised by inflammation of salivary and tear glands leading to dry eyes/mouth associated with fatigue and pain. These symptoms present in more than 80% of patients with major effect on quality of life because of disabling fatigue. To date, no treatment has been proven effective for pSS.
S95011 is a new biological therapy (monoclonal antibody) that blocks the activity of Interleukine-7 (IL-7) a specific protein in the body that promotes tissue inflammation by stimulating immune cells. Elevated levels of IL-7 and IL-7 receptors are found in the blood and tissues of pSS patients.
The primary objective of the study is to assess the effect of multiple intravenous infusions of 750 mg of S95011 compared to placebo after 13 weeks of treatment in reducing disease activity using European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). This dose has been chosen for this study, because after having analysed all the current available data, the blood concentration of the test drug is safe at this dose, whatever the patient’s weight.
45 healthy adult male and female volunteers were exposed to S95011 up to 10 mg/kg (single and multiple doses). Overall, the drug is considered to be safe in healthy volunteers.
The study will be run in NHS hospital sites in the UK and patients can be male/female aged 18 to 75 yrs inclusive. Expected study duration for patients is 30 weeks : screening period (2 weeks), double-blind treatment period (13 weeks). The administration schedule is one 60 minute IV infusion 750 mg every 2 weeks for the first month, then every 3 weeks until Week 10. After that, there will be a safety follow up period for 15 weeks.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0219
Date of REC Opinion
20 Oct 2020
REC opinion
Further Information Favourable Opinion