Efficacy and safety of two doses of Anifrolumab compared to placebo in adult subjects with Active Systemic Lupus Erythematosus

Study identifier:D3461C00005

ClinicalTrials.gov identifier:NCT02446912

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Medical condition

Active Systemic Lupus Erythematosus

Phase

Phase 3

Healthy volunteers

No

Study drug

Placebo

Sex

All

Actual Enrollment

460

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 09 Jun 2015
Primary Completion Date: 17 Jul 2018
Study Completion Date: 17 Jul 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PRA Health Sciences

Inclusion and exclusion criteria