A randomised, parallel-group, double-blind, placebo-controlled phase 3 study to Determine the effectiveness of the type I interferon receptor antibody, Anifrolumab, In SYstemic sclerosis: DAISY study design and rationale.
Dinesh KhannaChristopher P DentonShervin AssassiMasataka KuwanaYannick AllanoreRobyn T DomsicChristi KleoudisJohn XuEszter CsomorCaroline SeoMarius AlbulescuRaj TummalaHussein Al-MossawiRubana N KalyaniFrancesco Del GaldoPublished in: Clinical and experimental rheumatology (2024)
The DAISY trial will evaluate the efficacy and safety of anifrolumab as a first-in-class treatment option for patients with both limited and diffuse cutaneous SSc and will provide insight into the contributions of type I interferon to SSc pathogenesis. Revised-CRISS-25 can account for improvement and worsening in a broad set of validated clinical measures beyond lung function and skin thickness, including clinician- and patient-reported outcomes, capturing the heterogeneity of SSc.
Keyphrases
- placebo controlled
- double blind
- systemic sclerosis
- lung function
- patient reported outcomes
- phase iii
- clinical trial
- phase ii
- study protocol
- interstitial lung disease
- open label
- randomized controlled trial
- cystic fibrosis
- air pollution
- phase ii study
- dendritic cells
- chronic obstructive pulmonary disease
- systematic review
- single cell
- rheumatoid arthritis
- binding protein
- soft tissue
- wound healing
- replacement therapy