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Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

NCT04877691 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

Conditions

Interventions

DRUG

Medi-546

Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration.

DRUG

Placebo

Solution for injection in aPFS

Sponsors & Collaborators

  • IQVIA Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2025-08-22
Completion
2026-11-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Hungary
  • Japan
  • Mexico
  • Philippines
  • Poland
  • Spain
  • Thailand
  • Ukraine
  • 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 NCT04877691 on ClinicalTrials.gov