Determine effectiveness of Anifrolumab In SYstemic sclerosis (DAISY) - DAISY

Study identifier:D3460C00002

ClinicalTrials.gov identifier:NCT05925803

EudraCT identifier:N/A

CTIS identifier:2022-502142-26-00

Recruiting

Official Title

A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis

Medical condition

Systemic Sclerosis, Scleroderma

Phase

Phase 3

Healthy volunteers

No

Study drug

Anifrolumab (blinded), Placebo (blinded), Anifrolumab (unblinded, open label)

Sex

All

Estimated Enrollment

306

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 08 Nov 2023
Estimated Primary Completion Date: 09 Oct 2026
Estimated Study Completion Date: 31 Dec 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria