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
360
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
IQVIA
No locations available
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 |