The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).
This is a multicentre, randomised, phase I open-label study. The study will comprise of the following: * Screening period: Up to 30 days * Two treatment periods * Part A: Randomised SC vs IV Treatment Period: 5 weeks * Part B: Optional Extended Treatment Period: Up to 47 weeks * Safety follow-up period: 12 weeks after the final dose Part A will include all participants who will be randomised into SC anifrolumab via autoinjector (AI) or IV anifrolumab. Part B is an optional extended treatment period where participants will receive SC anifrolumab via accessorised prefilled syringe (aPFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Anifrolumab will be administered subcutaneously via an AI.
Anifrolumab will be administered intravenously.
Anifrolumab will be administered subcutaneously via an aPFS.
Anifrolumab serum concentrations through Week 4
To characterise the PK exposure of SC or IV anifrolumab.
Time frame: Up to Week 4
Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker
To characterise the PD of SC or IV anifrolumab.
Time frame: Up to Week 4
AstraZeneca Clinical Study Information Center
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