Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)

A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Combination product: Anifrolumab: SC formulation via AI; Combination product: Anifrolumab: IV formulation; Combination product: Anifrolumab: SC formulation via aPFS

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).

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: SC; Participants will receive SC anifrolumab administered via AI.	Combination product: Anifrolumab: SC formulation via AI; Anifrolumab will be administered subcutaneously via an AI.
Experimental: Part A: IV; Participants will receive IV anifrolumab infusion.	Combination product: Anifrolumab: IV formulation; Anifrolumab will be administered intravenously.
Experimental: Part B; Participants will receive SC anifrolumab administered via aPFS.	Combination product: Anifrolumab: SC formulation via aPFS; Anifrolumab will be administered subcutaneously via an aPFS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anifrolumab serum concentrations through Week 4	To characterise the PK exposure of SC or IV anifrolumab.	Up to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker	To characterise the PD of SC or IV anifrolumab.	Up to Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and B: Number of participants with adverse events (AEs)	To characterise the safety and tolerability of SC or IV anifrolumab in Part A and as SC administration alone in Part B.	Up to Week 64

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): April 13, 2029
• Study Completion (Estimated): June 14, 2030

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Monoclonal antibody; Pharmacokinetics; Systemic lupus erythematosus; Pharmacodynamics
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: D3466C00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes