MedTrace Logo

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

NCT05925803 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2026-04-20

No results posted yet for this 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

Interventions

COMBINATION_PRODUCT

Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

DRUG

Placebo (blinded)

matched placebo delivered subcutaneously, once weekly for 52 weeks

COMBINATION_PRODUCT

Anifrolumab (unblinded, open label)

At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2027-01-06
Completion
2028-04-05
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05925803 on ClinicalTrials.gov