20 Participants Needed

Anifrolumab for Lupus

(NAIVE Trial)

Recruiting at 4 trial locations
JT
CA
Overseen ByCristina Arriens, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Oklahoma Medical Research Foundation
Must be taking: Standard care immunosuppressants

Trial Summary

What is the purpose of this trial?

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.

Research Team

JT

Joan T Merrill, M.D.

Principal Investigator

Member

CA

Cristina Arriens, M.D.

Principal Investigator

Clinical Assistant Member

Eligibility Criteria

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.

Inclusion Criteria

Testing for Inclusion in the Study for those in the anifrolumab arm
Meets all of the following tuberculosis criteria
I will use a condom during sex from the start of the trial until 12 weeks after the last dose.
See 10 more

Exclusion Criteria

History of cancer, apart from
I haven't taken any restricted medications recently.
I have kidney inflammation and recent tests show stable kidney function.
See 19 more

Treatment Details

Interventions

  • Anifrolumab
  • Standard of Care
Trial OverviewThe 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.
Participant Groups
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

Anifrolumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Saphnelo for:
  • Moderate to severe systemic lupus erythematosus (SLE)
🇪🇺
Approved in European Union as Saphnelo for:
  • Moderate to severe systemic lupus erythematosus (SLE)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oklahoma Medical Research Foundation

Lead Sponsor

Trials
24
Recruited
8,400+

Piedmont Heart Institute, Inc., Atlanta, GA

Industry Sponsor

Trials
5
Recruited
1,800+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+