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Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE

NCT04726553 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-22

No results posted yet for this study

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.

Conditions

  • Systemic Lupus Erythematosus (SLE)

Interventions

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

Sponsors & Collaborators

  • NYU Langone Health

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Piedmont Heart Institute, Inc., Atlanta, GA

    collaborator INDUSTRY

  • Columbia University

    collaborator OTHER

  • Oklahoma Medical Research Foundation

    lead OTHER

Principal Investigators

  • Joan T Merrill, M.D. · Member

  • Cristina Arriens, M.D. · Clinical Assistant Member

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04726553 on ClinicalTrials.gov