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

NCT07688980 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: D3466C00003
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Monoclonal antibody; Pharmacokinetics; Pharmacodynamics; Safety; Systemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

• Anifrolumab serum concentrations through Week 4

  To characterise the PK exposure of SC or IV anifrolumab.

  Up to Week 4

Secondary Outcomes (1)

• Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker

  Up to Week 4

Other Outcomes (1)

• Part A and B: Number of participants with adverse events (AEs)

  Up to Week 64

Study Arms (3)

Part A: SC

EXPERIMENTAL

Participants will receive SC anifrolumab administered via AI.

Combination Product: Anifrolumab: SC formulation via AI

Part A: IV

EXPERIMENTAL

Participants will receive IV anifrolumab infusion.

Combination Product: Anifrolumab: IV formulation

Part B

EXPERIMENTAL

Participants will receive SC anifrolumab administered via aPFS.

Combination Product: Anifrolumab: SC formulation via aPFS

Interventions

Anifrolumab: IV formulation COMBINATION_PRODUCT

Anifrolumab will be administered intravenously.

Part A: IV

Anifrolumab: SC formulation via AI COMBINATION_PRODUCT

Anifrolumab will be administered subcutaneously via an AI.

Part A: SC

Anifrolumab: SC formulation via aPFS COMBINATION_PRODUCT

Anifrolumab will be administered subcutaneously via an aPFS.

Part B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Squamous or basal cell carcinoma of the skin treated with documented curative success ≥ 3 months prior to Day 1.
• Cervical cancer in situ treated with apparent curative success ≥ 1 year prior to Day 1.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): April 13, 2029
• Study Completion (Estimated): June 14, 2030
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.