Clinical Trial

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

Study acronym: DAISY
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2023-06-22; most recent amendment 2026-07-22.
Status change: Recruiting → Active, Not Recruiting 2026-02-02
Status change: Not Yet Recruiting → Recruiting 2024-01-08
Trial Details
NCT Number NCT05925803
Lead Sponsor AstraZeneca
Conditions Systemic Sclerosis, Scleroderma
Enrollment 314 participants
Start Date 2023-11-08
Primary Completion 2027-01-06 (estimated)
Study Completion 2028-04-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-23