drugset / Trial / NCT05925803

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

NCT05925803

Phase 3 Active not recruiting 314 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-11-08
Primary completion
2027-01-06
Completion
2028-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Anifrolumab Monoclonal antibody Subcutaneous

Indications