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Monoclonal Antibodies

Anifrolumab for Lupus (NAIVE Trial)

Phase < 1
Recruiting
Led By Cristina Arriens, M.D.
Research Sponsored by Oklahoma Medical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have moderate to severely active signs or symptoms defined as an SLE Disease Activity Index (SLEDAI) score of at least 6 or at least one moderately to severely active manifestation scoring B or A on British Isles Lupus Assessment Group (BILAG) Index
Be older than 18 years old
Must not have
Persistent toxicities as per Common Terminology Criteria for Adverse Events (CTCAE) that is > grade 2 and caused by current treatments
Any history of severe COVID-19 infection (e.g. requiring hospitalization, intensive care unit (ICU) care or assisted ventilation) or any prior COVID-19 infection with unresolved sequelae
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after vaccination (8 weeks after baseline)

Summary

This trial examines the effects of a new drug on SLE patients' disease activity, immune system, and response to a flu vaccine. 10 patients will get the drug and 10 won't, to compare.

Who is the study for?
This trial is for adults aged 18-70 with moderate to severely active Systemic Lupus Erythematosus (SLE), as indicated by specific disease activity scores. Participants may be on stable doses of certain lupus medications, including steroids and antimalarials. Women must use two forms of contraception, men must use condoms, and participants cannot be pregnant or have had recent severe infections or cancer.
What is being tested?
The study tests the effects of anifrolumab in addition to standard lupus care versus standard care alone on SLE disease activity and response to the flu vaccine. It involves 20 patients: half will receive anifrolumab plus standard treatments; the other half will only get standard treatments. All participants will be vaccinated against influenza.
What are the potential side effects?
Potential side effects are not explicitly listed but could include reactions related to immune system changes due to anifrolumab, such as infusion reactions or increased susceptibility to infections. Standard care side effects depend on the specific medications used but can range from stomach issues to changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lupus is active, with a SLEDAI score of 6 or more, or a BILAG score of A or B.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lasting side effects from treatment that are moderate to severe.
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I have never had severe COVID-19 requiring hospital care or have any lasting effects from a past infection.
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I haven't had major surgery in the last 8 weeks and don't plan any during the study.
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I have received the 2020-2021 flu vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after vaccination (8 weeks after baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after vaccination (8 weeks after baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in immune response to quadrivalent flu vaccine
Secondary study objectives
Proportion of patients who develop changes in autoantibodies after immunization with quadrivalent flu vaccine
Proportion of patients who develop flares after immunization with quadrivalent flu vaccine

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899
23%
Upper respiratory tract infection
16%
Nasopharyngitis
14%
Infusion related reaction
13%
Bronchitis
12%
Urinary tract infection
7%
Herpes zoster
7%
Sinusitis
6%
Cough
6%
Headache
6%
Back pain
6%
Arthralgia
4%
Nausea
2%
Pneumonia
1%
Lip squamous cell carcinoma
1%
Cervical dysplasia
1%
Angioedema
1%
Hypoaesthesia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Fall
1%
Nephrolithiasis
1%
Traumatic fracture
1%
Blood creatinine increased
1%
Osteonecrosis
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anifrolumab 300 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anifrolumab plus Standard of CareExperimental Treatment1 Intervention
Anifrolumab will be added to Standard of Care Treatments for SLE
Group II: Standard of CarePlacebo Group1 Intervention
Standard of Care Treatments for SLE
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Piedmont Heart Institute, Inc., Atlanta, GAIndustry Sponsor
4 Previous Clinical Trials
1,791 Total Patients Enrolled
NYU Langone HealthOTHER
1,411 Previous Clinical Trials
855,652 Total Patients Enrolled
Yale UniversityOTHER
1,927 Previous Clinical Trials
3,031,712 Total Patients Enrolled

Media Library

Anifrolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04726553 — Phase < 1
Systemic Lupus Erythematosus Research Study Groups: Anifrolumab plus Standard of Care, Standard of Care
Systemic Lupus Erythematosus Clinical Trial 2023: Anifrolumab Highlights & Side Effects. Trial Name: NCT04726553 — Phase < 1
Anifrolumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726553 — Phase < 1
~4 spots leftby Dec 2025
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