Tulip - Long Term Extension
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
IRAS ID
206295
Contact name
David D`Cruz
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-000625-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 1 days
Research summary
Summary of Research
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 antimalarials) 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 is a long-term extension study. Approximately 575 patients from Studies D3461C00004 or D3461C00005 who were previously treated with anifrolumab (150 or 300 mg) or placebo for 52 weeks while receiving standard of care treatment and who are willing to continue treatment may participate in the long-term extension study if all eligibility criteria are met.
Participants will receive anifrolumab (MEDI-546) 300 mg or placebo every 4 weeks from Week 0 to Week 152 for a total of 39 doses. Study medication anifrolumab or placebo will be administered intravenously over at least 30 minutes.
In this long-term extension study participants are 4 times more likely to receive anifrolumab than placebo. However, neither the participant not the study staff will know which treatment they are on.The primary objective is to characterise long-term safety and tolerability of intravenous anifrolumab.
The total study duration will be up to approximately 164 weeks (including a 12-week Follow-up Period after administration of the final dose).
The study is being conducted in approximately 302 locations throughout approximately 30 countries around the world.
Summary of Results
Please refer to the Trial Summary Results for the Lay Summary which can be found at the following website: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.trialsummaries.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C7f0c54f1feab47d52fa008dae3ae9b50%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638072636307735396%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=eDz731ec%2F4ZYTURreSVQRbW37V6iHKKOphPJFC2iSl0%3D&reserved=0
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0314
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion