Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) (DAISY)
Systemic Sclerosis, Scleroderma
About this trial
This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic Sclerosis (SSc), Scleroderma, Anifrolumab, Limited, Diffuse, Cutaneous, Interstitial lung disease (ILD), Autoimmune diseases, Immune system diseases, Immunosuppressants, Systemic Sclerosis interstitial lung disease (SSc- ILD)
Eligibility Criteria
Key Inclusion Criteria: Adult patients from 18 to 70 years of age inclusive Systemic sclerosis according to 2013 ACR/EULAR classification criteria Limited or diffuse cutaneous subsets Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points mRSS > 10 with early disease or rapid progression as defined by the protocol mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolic sodium, mycophenolic acid, oral glucocorticoids or tacrolimus Women of childbearing potential with a negative urine pregnancy test Uninvolved skin at injection sites Key Exclusion Criteria: Anticentromere antibody seropositivity on central laboratory Severe cardiopulmonary disease as defined by the protocol History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min) Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis) History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator Hematopoietic stem cell transplantation or solid organ/limb transplantation Any severe case of Herpes Zoster infection as defined by the protocol Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix Major surgery within 8 weeks prior to and/or during study enrollment Known active current or history of recurrent infections Severe cardiopulmonary disease Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Anifrolumab (subcutaneous weekly injection)
matched placebo control (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly
matched placebo control subcutaneous injection once weekly