NCT04726553

Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE

Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in Patients With Moderately to Severely Active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial:

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oklahoma Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study to examines the impact of anifrolumab on disease activity, immune phenotypes, and development of neutralizing antibodies to quadrivalent influenza vaccine in patients with Systemic Lupus Erythematosus (SLE). 10 patients with moderately to severely active SLE will be treated with anifrolumab in addition to standard of care lupus treatments and 10 will receive only standard of care medications. All will receive influenza vaccine.

Detailed description

This group of researchers previously observed that lupus patients with an elevated interferon alpha signal produced less neutralizing antibody to influenza vaccine which was directly or indirectly associated with increased flares and autoantibody production after immunization. Anifrolumab is an inhibitor of signaling through the Type I interferon alpha beta receptor. The current study is an open label parallel group pilot study to examine the impact of anifrolumab on development of neutralizing antibodies to quadrivalent influenza vaccine in patients with SLE. 10 patients with moderately to severely active SLE will initiate treatment with anifrolumab while continuing standard of care medications and 10 will receive only standard of care medications. Two weeks after baseline all will receive influenza vaccine. Blood samples will be drawn at baseline (Day 0), just prior to immunization (Week 2), and Weeks 4, 8, 12 and 16. Disease activity, gene/cytokine expression, autoantibody production and patient reported outcomes will also be tracked.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	Anifrolumab	Anifrolumab is a monoclonal antibody which inhibits the Interferon alpha beta receptor (IFNAR) which is the main transducer of signals from Type I interferons.
DRUG	Standard of Care	Standard of Care treatments for Systemic Lupus Erythematosus

Timeline

• Start date: 2021-01-20
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-01-27
• Last updated: 2023-03-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study