NCT04877691

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age. Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the primary endpoint evaluated at Week 52. Subjects who complete Week 52 may enter into open-label extension (OLE). All patients who enter the OLE Period will receive a fixed subcutaneous dose of anifrolumab for up to 52 weeks. Study intervention will be administered SC via an accessorised prefilled syringe (aPFS).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-08
• Primary completion: 2025-08-22
• Completion: 2026-11-06
• First posted: 2021-05-07
• Last updated: 2026-04-17

Locations

140 sites across 15 countries: United States, Argentina, Bulgaria, Chile, Colombia, Germany, Hungary, Japan, Mexico, Philippines, Poland, Spain, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study