Systemic Lupus Erythematosus
Conditions
Keywords
Monoclonal antibody, Pharmacokinetics, Pharmacodynamics, Safety, Systemic lupus erythematosus
Brief summary
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).
Detailed description
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).
Interventions
COMBINATION_PRODUCTAnifrolumab: SC formulation via AI
Anifrolumab will be administered subcutaneously via an AI.
COMBINATION_PRODUCTAnifrolumab: IV formulation
Anifrolumab will be administered intravenously.
COMBINATION_PRODUCTAnifrolumab: SC formulation via aPFS
Anifrolumab will be administered subcutaneously via an aPFS.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants who have a diagnosis of adult SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 criteria for ≥ 24 weeks prior to signing the informed consent form (ICF). * "Clinical" Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4 points at Screening. * Antinuclear antibody (ANA)-positive at Screening. * Must be on stable background standard therapy with oral corticosteroids (OCS), antimalarials, and/or immunosuppressants alone or in combination.
Exclusion criteria
* Active severe or unstable neuropsychiatric SLE. * Active severe SLE-driven renal disease. * Known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection, or a positive result for Human Immunodeficiency Virus (HIV) infection confirmed by central laboratory at Screening. * At Screening, confirmed positive test for hepatitis B serology or positive test for hepatitis C antibody. * Any severe case of herpes zoster infection at any time prior to Week 0 (Day 1). * Opportunistic infection requiring hospitalisation or IV antimicrobial treatment within 3 years of randomisation * History of cancer, apart from: 1. Squamous or basal cell carcinoma of the skin treated with documented curative success ≥ 3 months prior to Day 1. 2. Cervical cancer in situ treated with apparent curative success ≥ 1 year prior to Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anifrolumab serum concentrations through Week 4 | Up to Week 4 | To characterise the PK exposure of SC or IV anifrolumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker | Up to Week 4 | To characterise the PD of SC or IV anifrolumab. |
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed