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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after vaccination (8 weeks after baseline)
Awards & highlights

NAIVE Trial 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.Check my eligibility
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.See study design
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.

NAIVE Trial Eligibility Criteria

Inclusion Criteria

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

NAIVE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in immune response to quadrivalent flu vaccine
Secondary outcome measures
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%
Angioedema
1%
Hypoaesthesia
1%
Cervical dysplasia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Lip squamous cell carcinoma
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

NAIVE 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
1,368 Previous Clinical Trials
839,706 Total Patients Enrolled
Yale UniversityOTHER
1,851 Previous Clinical Trials
2,738,193 Total Patients Enrolled

Media Library

Anifrolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04726553 — Phase < 1
Lupus Research Study Groups: Anifrolumab plus Standard of Care, Standard of Care
Lupus 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior research has been done involving Anifrolumab?

"Presently, there are 331 Anifrolumab studies in progress. 78 of these trials have reached Phase 3 and are based primarily out of Philadelphia, Pennsylvania; yet 8054 sites across the globe offer medical research into this new medication."

Answered by AI

How is Anifrolumab usually applied to aid patients?

"Anifrolumab is most frequently administered to individuals with lupus erythematosus, systemic. Nonetheless, it also has applications in battling bladder cancer, pericarditis, and meningeal leukemia."

Answered by AI

Who meets the prerequisites to participate in this trial?

"Eligible patients must demonstrate a diagnosis of lupus, and they should be in the 18-70 age range. This trial will enrol 20 participants total."

Answered by AI

How many individuals have signed up to participate in this experiment?

"The Piedmont Heart Institute, Inc., Atlanta, GA is responsible for carrying out the trial from two distinct settings: Piedmont Hospital in Atlanta and New york University Medical Center. To undertake this study there needs to be 20 individuals that adhere to its inclusion criteria."

Answered by AI

Is the age limit for participating in this experiment restricted to those under 40 years old?

"The study is open to applicants aged between 18 and 70, although there are more trials available for younger (149) or elderly (340) patients."

Answered by AI

Is this scientific research accepting volunteers at the present time?

"As can be found on clinicaltrials.gov, this medical trial is actively looking for participants to take part in their program. The initial post was uploaded on January 20th 2021 and the most recent update occurred on March 21st 2023."

Answered by AI

Are any North American centers conducting this research experiment?

"Currently, this medical trial is enrolling participants in Piedmont Hospital of Atlanta (GA), New york University Medical Center (NY) and Columbia Unversity Medical Center (OKC) as well as 5 additional sites."

Answered by AI

Who else is applying?

What site did they apply to?
New York University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE
2021. "Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726553.
All > Systemic Lupus Erythematosus > Lupus
~5 spots leftby Apr 2025
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