Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
Condition(s) studied
Investigational drug(s) / intervention(s)
Anifrolumab (blinded): Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo (blinded): matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label): At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
Study 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.
Eligibility
Primary outcome measure(s)
- Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25) — at Week 52
Number of participants meeting all the criteria: * Improvement in at least 2 components (≥5% increase for percent predicted Forced Vital Capacity (FVC) and/or≥25% decrease for Modified Rodnan Skin Score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PtGA), Clinician Global Assessment (CGA) * Worsening in no more than one component (≥5% decrease percent predicted FVC and/or≥25% increase for mRSS, HAQ-DI, PtGA, CGA) * No significant SSc-related event as defined by: New scleroderma renal crisis New decline in percent predicted FVC≥15% in established interstitial lung disease or new percent predicted FVC below 80% predicted New onset of left ventricular failure requiring treatment New onset of pulmonary arterial hypertension requiring treatment Gastrointestinal dysmotility requiring enteral or parenteral nutrition Digital ischemia with gangrene, amputation, or hospitalization requiring treatment -Otherwise, a participant is a non-responder
Trial sites (150)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Scottsdale | Arizona | |
| Research Site | Chula Vista | California | |
| Research Site | Los Angeles | California | |
| Research Site | Orange | California | |
| Research Site | Aurora | Colorado | |
| Research Site | New Haven | Connecticut | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Boca Raton | Florida | |
| Research Site | Fort Lauderdale | Florida | |
| Research Site | Gainesville | Florida | |
| Research Site | Jacksonville | Florida | |
| Research Site | Margate | Florida | |
| Research Site | South Miami | Florida | |
| Research Site | Tamarac | Florida | |
| Research Site | Chicago | Illinois | |
| Research Site | Kansas City | Kansas | |
| Research Site | New Orleans | Louisiana | |
| Research Site | Baltimore | Maryland | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Rochester | Minnesota | |
| Research Site | Babylon | New York | |
| Research Site | New York | New York | |
| Research Site | Cincinnati | Ohio | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Allen | Texas | |
| Research Site | Houston | Texas | |
| Research Site | Graz | Austria | |
| Research Site | Innsbruck | Austria | |
| Research Site | Vienna | Austria | |
| Research Site | Ghent | Belgium | |
| Research Site | Leuven | Belgium | |
| Research Site | Calgary | Alberta | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Montreal | Quebec | |
| Research Site | Québec | Quebec | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China | |
| Research Site | Guangzhou | China | |
| Research Site | Guangzhou | China |
+ 110 more sites — see the full list on the official registry below.
More AstraZeneca trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05925803 on ClinicalTrials.gov ↗ ← All trials in South Korea