Anifrolumab Asian PhIII efficacy study for Systemic Lupus Erythematosus (SLE)

Study identifier:D3468C00003

ClinicalTrials.gov identifier:NCT04931563

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants with Active Systemic Lupus Erythematosus

Medical condition

Active Systemic Lupus Erythematosus

Phase

Phase 3

Healthy volunteers

No

Study drug

placebo

Sex

All

Actual Enrollment

276

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 13 Sept 2021
Estimated Primary Completion Date: 09 Apr 2025
Estimated Study Completion Date: 09 Apr 2025

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria