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Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

NCT02794285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2023-01-13

Study results available
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Summary

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

Conditions

  • Active Systemic Lupus Erythematosus

Interventions

BIOLOGICAL

Anifrolumab

Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

DRUG

Placebo

Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Kenneth Kalunian, MD · University of California, San Diego

  • Raj Tummala, MD · 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
2016-06-30
Primary Completion
2021-12-21
Completion
2021-12-21

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Hungary
  • Israel
  • Japan
  • Lithuania
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • 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 NCT02794285 on ClinicalTrials.gov