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NCT05925803 · ClinicalTrials.gov registry record · Phase 3
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
A Phase 3 study of Systemic Sclerosis and Scleroderma, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
- 20
- Study locations
NCT05925803: Active Phase 3 study of Systemic Sclerosis and Scleroderma, sponsored by AstraZeneca.
NCT05925803 is a Phase 3 study of Systemic Sclerosis and Scleroderma that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 314 participants, above the 267-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05925803, a Phase 3 study of Systemic Sclerosis and Scleroderma, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- COMBINATION_PRODUCT Anifrolumab (blinded)
- COMBINATION_PRODUCT Anifrolumab (unblinded, open label)
- DRUG Placebo (blinded)
Study Locations (20)
Florida
- Research Site - Boca Raton
- Research Site - Fort Lauderdale
- Research Site - Gainesville
- Research Site - Jacksonville
- Research Site - Margate
- Research Site - South Miami
- Research Site - Tamarac
California
- Research Site - Chula Vista
- Research Site - Los Angeles
- Research Site - Orange
Arizona
- Research Site - Scottsdale
Colorado
- Research Site - Aurora
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Illinois
- Research Site - Chicago
Kansas
- Research Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2028-04-05 |
| Phase | Phase 3 |
What the registry record for NCT05925803 still lists
NCT05925803 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, above the 267-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (18% higher).
The record links to 2 conditions, with Systemic Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Anifrolumab (blinded) is the first listed.
NCT05925803 names 20 study sites across 12 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05925803 about?
NCT05925803 is a clinical study titled "Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)". 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 ...
What is the current status of trial NCT05925803?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2023-11-08. Estimated completion is 2028-04-05.
What conditions does trial NCT05925803 study?
This clinical trial studies the following conditions: Systemic Sclerosis, Scleroderma.
What interventions are being tested in trial NCT05925803?
The interventions under investigation include: Anifrolumab (blinded) (COMBINATION_PRODUCT), Anifrolumab (unblinded, open label) (COMBINATION_PRODUCT), Placebo (blinded) (DRUG).
Who is sponsoring clinical trial NCT05925803?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05925803 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05925803's enrollment target sits among peer trials
314 3rd of 26 higher than 24 of 26 other Systemic Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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