A study to characterize the Pharmacokinetics, Pharmacodynamics, and Safety of anifrolumab in adult type I Interferon test high Systemic Lupus Erythematosus subject with active skin manifestations
Study identifier:D3461C00008
ClinicalTrials.gov identifier:NCT02962960
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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.
Medical condition
Systemic Lupus Erythematosus
Phase
Phase 2
Healthy volunteers
No
Study drug
Anifrolumab, Placebo
Sex
All
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 14 Feb 2017
Primary Completion Date: 22 Jan 2018
Study Completion Date: 17 Dec 2018
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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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 |
