Study identifier:D3461C00008
ClinicalTrials.gov identifier:NCT02962960
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations.
Systemic Lupus Erythematosus
Phase 2
No
Anifrolumab, Placebo
All
36
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2019 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab - Lower dose 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | Drug: Anifrolumab subcutaneous administration every 2 weeks from week 0 to week 50 |
Placebo Comparator: Placebo matching for lower dose of Anifrolumab 1ml, once every second week, one subcutaneous injection added to stand of care, from week 0 to week 50 | Drug: Placebo subcutaneous administration every two weeks from week 0 to week 50 |
Experimental: Anifrolumab - Higher dose 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Drug: Anifrolumab subcutaneous administration every 2 weeks from week 0 to week 50 |
Placebo Comparator: Placebo matching for higher dose of Anifrolumab 2×1ml , once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | Drug: Placebo subcutaneous administration every two weeks from week 0 to week 50 |