Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

About

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

70 Years

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 at the time of signing the ICF
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, mycophenolate 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/1.73m2)
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
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