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Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

NCT02547922 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2021-11-24

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

Conditions

Interventions

BIOLOGICAL

Anifrolumab

Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112

DRUG

Placebo

Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • AstraZeneca AB · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2019-11-26
Completion
2021-01-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Peru
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02547922 on ClinicalTrials.gov