TULIP-LN1
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Proliferative Lupus Nephritis
IRAS ID
186580
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-001442-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 0 days
Research summary
Lupus is an autoimmune disease, which means that the immune system not only attacks bacteria and viruses but also attacks healthy cells and organs, affecting many parts of the body. When lupus affects the kidneys, it is known as lupus nephritis. This may result in inflammation of kidneys and may lead to blood in the urine, protein in the urine, high blood pressure, and loss of kidney function or kidney failure.
The study drug, anifrolumab, is a man-made monoclonal antibody (artificially made in a laboratory) which blocks the actions of all type I interferons, and these seem very likely to have a role in autoimmune diseases, such as lupus and lupus nephritis.
Currently there is no approved medication for lupus nephritis, but various treatment regimens (that suppress the immune system, such as, mycophenolate mofetil, cyclophosphamide, and corticosteroids) are widely used as local standards of care.
The purpose of this study is to see if anifrolumab may have an effect in treating lupus nephritis, to see how well it is tolerated, and to measure levels of anifrolumab in the blood.
This study includes a screening period, treatment period, follow up and eligible participants will be offered treatment in a long-term extension study. Participants will either receive anifrolumab or placebo.
The study is double-blinded so neither the participant nor the doctor will know which treatment has been assigned throughout the study.
This is a multicentre study which will take place worldwide in approximately 80 sites. It is anticipated that around 150 participants will be enrolled. This study is sponsored by the pharmaceutical company, AstraZeneca AB.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0081
Date of REC Opinion
4 Apr 2016
REC opinion
Further Information Favourable Opinion