Tulip Study: Anifrolumab in Adults with Active SLE
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
IRAS ID
181870
Contact name
Eva Barkstedt
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-004633-96
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 28 days
Research summary
This study is being carried out to see whether the medication Anifrolumab in combination with a patient’s current lupus treatment is effective in reducing the severity of their lupus disease. The study will recruit 450 participants from 173 sites across 18 countries around the world.
Lupus – short for systemic lupus erythematosus - is an autoimmune condition, which means that instead of protecting the body from infection or illness, the immune system reacts abnormally and starts attacking healthy cells and tissue. Lupus can cause fever, joint pain, rash, sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage. Current lupus treatments include medications that suppress the immune system such as cortisone-like medications (e.g. prednisone), cyclophosphamide (a potent medication sometimes used in treating certain types of cancer), and medications commonly used to treat or prevent malaria (called anti-malarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time. Therefore, there is a need for new and effective treatments for lupus.
This study will evaluate two different doses of Anifrolumab and compare their effectiveness against a placebo. A placebo is a ‘dummy treatment’, which looks like the genuine medicine but contains no active ingredient. Patients that join this study will have a three in five chance of receiving Anifrolumab and a two in five chance of receiving the placebo. It will take each participant 17 or 18 study visits over about 64 weeks to complete the study.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0543
Date of REC Opinion
16 Jul 2015
REC opinion
Further Information Favourable Opinion