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Monoclonal Antibodies
Anifrolumab for Lupus
Phase 2
Recruiting
Led By Mariana J Kaplan, M.D.
Research Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Summary
This trial will test whether the drug anifrolumab improves blood vessel function and reduces blood vessel inflammation in people with SLE.
Who is the study for?
Adults aged 18-80 with Systemic Lupus Erythematosus (SLE) are eligible for this trial. They must be in good health or have stable lupus, on consistent medication for at least 4 weeks, and not planning to change their meds during the trial. Participants need a history of vaccination against COVID-19 and Varicella Zoster, use effective contraception if applicable, and cannot have had recent severe cardiovascular events or other serious health conditions.
What is being tested?
The study is testing anifrolumab's effectiveness in improving blood vessel function and reducing inflammation compared to a placebo. Participants will receive infusions without knowing which treatment they get. The study involves nine clinic visits over eight months with tests like CAVI for blood vessel function and FDG-PET/CT scans for imaging body inflammation.
What are the potential side effects?
Potential side effects of anifrolumab may include reactions at the infusion site, increased risk of infections due to immune system suppression, possible allergic reactions, as well as general symptoms such as fatigue or headaches. Specific side effect profiles will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
role of anifrolumab
Secondary study objectives
Role of anifrolumab
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: PatientActive Control1 Intervention
anifrolumab
Group II: Patient placeboPlacebo Group1 Intervention
placebo
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Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor
496 Previous Clinical Trials
1,089,467 Total Patients Enrolled
2 Trials studying Lupus
270 Patients Enrolled for Lupus
Mariana J Kaplan, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
2 Previous Clinical Trials
438 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 80 years old.I am generally healthy or have been diagnosed with lupus according to specific criteria.I am vaccinated against COVID-19 and Varicella Zoster or have antibodies.I haven't had major surgery in the last 8 weeks and don't plan any during the study.My lupus treatment has been stable for at least 4 weeks.My medications for diabetes, high blood pressure, or cholesterol have been stable for the last 3 months.I have been taking 10 mg or less of Prednisone daily for at least 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Patient placebo
- Group 2: Patient
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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