Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

Launched by ASTRAZENECA · Jun 22, 2023

Keywords

ClinConnect Summary

The DAISY clinical trial is studying the effectiveness and safety of a new treatment called anifrolumab for adults with systemic sclerosis, also known as scleroderma. This trial is specifically aimed at patients who have been diagnosed with either the limited or diffuse forms of the disease and have experienced symptoms for less than six years. To participate, individuals must be between 18 and 70 years old and meet certain criteria related to their condition, including specific measures of disease severity.

Participants in this trial will receive either the anifrolumab treatment or a placebo (a substance with no therapeutic effect) and will be monitored throughout the study to see how well the treatment works and if there are any side effects. The trial is currently recruiting participants, so if you or a loved one meets the eligibility criteria, this could be a valuable opportunity to contribute to research that may help improve treatment for systemic sclerosis. It’s important to discuss with your doctor to see if this trial is a suitable option for you.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Adult patients from 18 to 70 years of age inclusive
• • 2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria
• • 3. Limited or diffuse cutaneous subsets
• • 4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
• • 5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
• • 6. mRSS \> 10 with early disease or rapid progression as defined by the protocol
• • 7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
• • 8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
• • 9. Women of childbearing potential with a negative urine pregnancy test
• • 10. Uninvolved skin at injection sites
• Key Exclusion Criteria:
• • 1. Anticentromere antibody seropositivity on central laboratory
• • 2. Severe cardiopulmonary disease as defined by the protocol
• • 3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2)
• • 4. 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)
• • 5. 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
• • 6. 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
• • 7. Hematopoietic stem cell transplantation or solid organ/limb transplantation
• • 8. Any severe case of Herpes Zoster infection as defined by the protocol
• • 9. 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
• • 10. Major surgery within 8 weeks prior to and/or during study enrollment
• • 11. Known active current or history of recurrent infections
• • 12. 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