Anifrolumab for Lupus

Yale University Medical Center, New Haven, CT
LupusAnifrolumab - Drug
18 - 70
All Sexes

Study 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.

Eligible Conditions
  • Lupus

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 6 weeks after vaccination (8 weeks after baseline)

Week 8
Change in immune response to quadrivalent flu vaccine
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

Trial Safety

Side Effects for

Anifrolumab 300 mg
23%Upper respiratory tract infection
14%Infusion related reaction
12%Urinary tract infection
7%Herpes zoster
6%Back pain
1%Acute coronary syndrome
1%Gastroenteritis viral
1%Blood creatinine increased
1%Systemic lupus erythematosus
1%Traumatic fracture
1%Cervical dysplasia
1%Chilaiditi's syndrome
1%Lip squamous cell carcinoma
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02446899) in the Anifrolumab 300 mg ARM group. Side effects include: Upper respiratory tract infection with 23%, Nasopharyngitis with 16%, Infusion related reaction with 14%, Bronchitis with 13%, Urinary tract infection with 12%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Anifrolumab plus Standard of Care
1 of 2
Standard of Care
1 of 2

Experimental Treatment

Non-Treatment Group

20 Total Participants · 2 Treatment Groups

Primary Treatment: Anifrolumab · Has Placebo Group · Phase < 1

Anifrolumab plus Standard of Care
Experimental Group · 1 Intervention: Anifrolumab · Intervention Types: Drug
Standard of Care
PlaceboComparator Group · 1 Intervention: Standard of Care · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks after vaccination (8 weeks after baseline)

Who is running the clinical trial?

Columbia UniversityOTHER
1,337 Previous Clinical Trials
1,642,409 Total Patients Enrolled
Oklahoma Medical Research FoundationLead Sponsor
20 Previous Clinical Trials
7,887 Total Patients Enrolled
NYU Langone HealthOTHER
1,306 Previous Clinical Trials
761,766 Total Patients Enrolled
Yale UniversityOTHER
1,728 Previous Clinical Trials
20,525,556 Total Patients Enrolled
Piedmont Heart Institute, Inc., Atlanta, GAIndustry Sponsor
4 Previous Clinical Trials
1,791 Total Patients Enrolled
Joan T Merrill, M.D.Study DirectorMember
Cristina Arriens, M.D.Principal InvestigatorClinical Assistant Member

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is this scientific research accepting volunteers at the present time?

"As can be found on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.