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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 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.

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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.

Conditions Studied

Systemic Sclerosis Scleroderma

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

FieldValue
Enrollment Target 314 participants
Start Date 2023-11-08
Est. Completion 2028-04-05
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05925803

The ClinicalTrials.gov registry entry for NCT05925803 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 267-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (18% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.