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:N/A

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

Actual enrollment

360

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 15 Feb 2022
Estimated Primary Completion Date: 02 Apr 2026
Estimated Study Completion Date: 08 Jul 2027

Study design

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

Verification:

Verified 01 Jan 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria