Study identifier:D3465C00001
ClinicalTrials.gov identifier:NCT04877691
EudraCT identifier:2020-004529-22
CTIS identifier:2024-513031-24-00
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
Systemic Lupus Erythematosus
Phase 3
No
Medi-546, Placebo
All
367
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2024 by AstraZeneca
AstraZeneca
IQVIA
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
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).
Location
Location
Brooklyn, NY, United States, 11201
Location
Reading, PA, United States, 19610
Location
Brandon, FL, United States, 33511
Location
Idaho Falls, ID, United States, 83404
Location
Miami, FL, United States, 33180
Location
Oklahoma City, OK, United States, 73104
Location
Phoenix, AZ, United States, 85032
Location
Upland, CA, United States, 91786
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab Solution for injection in aPFS | 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. Other Name: MEDI-546 |
Placebo Comparator: Placebo Solution for injection in aPFS | Drug: Placebo Solution for injection in aPFS |
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