*DAISY
Research type
Research Study
Full title
A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis
IRAS ID
1007434
Contact name
Manika Azad
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-502142-26
Research summary
The purpose of this study is to evaluate the safety and efficacy of anifrolumab in adult patients with systemic sclerosis (scleroderma) who may be taking one or a combination of protocol specified standard therapies. The information the study sponsor receives from this study may
help to treat patients with scleroderma better in the future. Scleroderma affects the skin as well as other organs. It is believed that an excess of certain immune system proteins (type1 interferons) play an important role in this disease. Anifrolumab is a man-made antibody that blocks type 1 interferons. Blocking type I interferons with anifrolumab may reduce disease activity and address overall disease progression including skin and lung inflammation. Anifrolumab is being tested in research studies as a new treatment for scleroderma and the purpose of this study is to find out if anifrolumab is safe to use in scleroderma and can improve the symptoms of the disease.
The study will be conducted in approximately 165 centers in 21 countries. About 306 people will take part in this study. Half of the participants will receive 120 mg anifrolumab and half will receive placebo (solution containing no anifrolumab) by injection under the skin while continuing to receive their standard therapies. After 52 weeks of double-blinded and placebo controlled
treatment, there will be an open-label treatment period where all participants will receive anifrolumab. Patients will be in the study for approximately 122 weeks. During this period, some tests and procedures will be performed on study patients, including questions about the patient, skin thickness assessment, lung function test, physical examination, chest computed tomography (or
chest X-Ray), electrocardiography, pap smear test (women only), echocardiograms, blood tests, urinalysis, pregnancy test, assessment of digital ulcer, cardiovascular risk assessment, COVID- 19 assessment, blood pressure, heart rate and body temperature will be measured.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0146
Date of REC Opinion
18 Sep 2023
REC opinion
Further Information Favourable Opinion