Patient for Lupus Erythematosus, Systemic

Phase-Based Progress Estimates
National Institutes of Health Clinical Center, Bethesda, MD
Lupus Erythematosus, Systemic+5 More
anifrolumab - Drug
All Sexes
What conditions do you have?

Study Summary

Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Objective: To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE. Eligibility: People aged 18 to 80 years with SLE. Design: Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms. Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours. Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting. At some visits they will have additional tests: CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms. FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.

Eligible Conditions

  • Lupus Erythematosus, Systemic
  • Premature Atherosclerosis
  • Cardiovascular Disease (CVD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lupus Erythematosus, Systemic

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 8 months

8 months
Role of anifrolumab
role of anifrolumab

Trial Safety

Safety Progress

1 of 3

Other trials for Lupus Erythematosus, Systemic

Trial Design

2 Treatment Groups

1 of 2
Patient placebo
1 of 2
Active Control
Non-Treatment Group

45 Total Participants · 2 Treatment Groups

Primary Treatment: Patient · Has Placebo Group · Phase 1

ActiveComparator Group · 1 Intervention: anifrolumab · Intervention Types: Drug
Patient placebo
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2016First Recorded Clinical Trial
6 TrialsResearching Lupus Erythematosus, Systemic
271 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor
443 Previous Clinical Trials
1,069,486 Total Patients Enrolled
29 Trials studying Lupus Erythematosus, Systemic
22,342 Patients Enrolled for Lupus Erythematosus, Systemic
Mariana J Kaplan, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
2 Previous Clinical Trials
438 Total Patients Enrolled
1 Trials studying Lupus Erythematosus, Systemic
88 Patients Enrolled for Lupus Erythematosus, Systemic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of reproductive potential.\n
You are willing to comply with all study procedures and are available for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.