Phase 3 Study of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis - IRIS

Study identifier:D3466C00001

ClinicalTrials.gov identifier:NCT05138133

EudraCT identifier:2021-002862-42

CTIS identifier:2023-506359-68-00

Recruiting

Official Title

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis

Medical condition

Lupus Nephritis

Phase

Phase 3

Healthy volunteers

No

Study drug

Anifrolumab, Placebo

Sex

All

Estimated Enrollment

346

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 15 Feb 2022
Estimated Primary Completion Date: 30 Sept 2026
Estimated Study Completion Date: 07 Jul 2028

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