Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE — NAIVE  

Systemic Lupus Erythematosus (SLE) Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus (SLE)

• NCT number: NCT04726553
• Study type: Interventional
• Source: Oklahoma Medical Research Foundation
• Contact: Joan T Merrill, M.D.
• Phone: 14058222336
• Email: joan-merrill@omrf.org
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 20, 2021
• Completion date: December 31, 2024