NCT04931563 is a Phase 3 clinical trial of Anifrolumab in Active Systemic Lupus Erythematosus, sponsored by AstraZeneca.

Who is sponsoring NCT04931563?

NCT04931563 is sponsored by AstraZeneca.

What drugs are being tested in NCT04931563?

Interventions in NCT04931563: Anifrolumab, placebo.

What condition does NCT04931563 study?

NCT04931563 studies Active Systemic Lupus Erythematosus.

Is NCT04931563 still recruiting?

NCT04931563 is currently completed. Last updated 16 October 2025.

Last reviewed 2025-10-16 · How we verify

NCT04931563

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Completed Phase 3 Last updated 16 October 2025

What this trial tests

Phase 3 trial testing Anifrolumab in Active Systemic Lupus Erythematosus in 277 participants. Completed in 10 June 2025.

Timeline

13 September 2021

Primary endpoint
7 April 2025

10 June 2025

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	277
Start date	13 September 2021
Primary completion	7 April 2025
Estimated completion	10 June 2025
Sites	65 locations across Hong Kong, Taiwan, South Korea, Philippines, Thailand, China

Drugs / interventions tested

Anifrolumab (ANIFROLUMAB) — full drug profile →
placebo

Conditions studied

Active Systemic Lupus Erythematosus — all drugs for Active Systemic Lupus Erythematosus →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 70, any sex, with Active Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Interferon Inhibition in SLE: From Bench to Bedside.
Deligeorgakis D, Skouvaklidou E, Adamichou C. · · 2024 · cited 3× · PMID 39193183 · DOI 10.31138/mjr.010324.iis
How will we treat systemic lupus erythematosus in the next 5 years?
Zhao J, Tian X, Li M, Zeng X. · · 2025 · PMID 41050476 · DOI 10.1515/rir-2025-0016

Verify or expand the search:

Other trials of Anifrolumab

Trials testing the same drug.

NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07430306 — A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Sys · Phase 3 · not yet recruiting
NCT07000110 — Anifrolumab Malignancy and Serious Infections Study · recruiting
NCT06594068 — Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users · Phase 4 · recruiting
NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04931563 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 16 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04931563.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing