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

NCT02446912 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2023-01-12

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 moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Conditions

  • Active Systemic Lupus Erythematosus

Interventions

BIOLOGICAL

Anifrolumab

Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses

DRUG

Placebo

Placebo IV administration every 4 weeks from Week 0 to Week 48

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Herbert Hutman, MD · Medical Science Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-09
Primary Completion
2018-07-17
Completion
2018-07-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • Colombia
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Peru
  • Poland
  • Romania
  • South Korea
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02446912 on ClinicalTrials.gov