The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD

NCT05440422 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10000682000682-AR
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus; Cardiovascular Disease; Premature Atherosclerosis

Keywords

Vascular Inflammation; Interferons; Vascular Function

Outcome Measures

Primary Outcomes (1)

• role of anifrolumab

  1.Change from Baseline (Week 0) to Week 28 in cardio-ankle vascular index (CAVI). 2. Change from Baseline to Week 28 in pulse wave velocity (PWV) using Sphygmocor. 3. Change from Baseline to Week 28 in vascular inflammation as measured by target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scans.

  8 months

Secondary Outcomes (1)

• Role of anifrolumab

  8 months

Study Arms (2)

Patient

ACTIVE COMPARATOR

anifrolumab

Drug: anifrolumab

Patient placebo

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

anifrolumab DRUG

This is a double blind placebo-controlled study to characterize whether blocking type I IFN receptor signaling with anifrolumab will lead to improvements in vascular function, decreases in vascular inflammation and modulation of biomarkers of vascular risk in patients with SLE.

Patient

Placebo OTHER

non-active substance comprised of 25 mM histidine/histidine-HCl, 50 mM lysine-HCl, 130 mM trehalose, and 0.05% (w/v) polysorbate 80, with a pH of 5.9.

Patient placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-80 years
• In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.
• Prednisone \< or equal to 10 mg/day for at least 2 weeks before screening and maintained throughout randomization (day 1)
• Stable standard of care lupus therapies for at least 4 weeks before screening and maintained through randomization (day 1)
• Abnormal cardio-ankle vascular index(CAVI) at screening OR up to 90 days prior to the screening visit (based on 2 SD above median of healthy controls based on historical data from our own patient cohorts
• Stable medications for diabetes, hypertension and/or statins for at least the previous 3 months. No changes of these medications or immunosuppressive drugs will be allowed during trial.
• For females and males of reproductive potential: use of highly effective contraception from screening and agreement to use such a method during study participation and for an additional 16 weeks after the end of study medication administration. For the purpose of this study abstinence will be considered as an effective form of contraception.
• Subjects must confirm receipt of prior vaccination against COVID-19 and Varicella Zoster. Verbal confirmation of vaccination receipt AND detectable antibodies in serum is acceptable in the absence of vaccine records.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this
• study:
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
• Concurrent enrolment in another clinical study with an investigational product
• Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.
• Any of the following found at Screening:
• Aspartate aminotransferase (AST) \>2.5 x upper limit of normal (ULN).
• Alanine aminotransferase (ALT) \>2.0 x ULN.
• Total bilirubin \>ULN (unless due to Gilbert's syndrome)
• Serum creatinine \>2.5 mg/dL (or \>181 micromol/L)
• Urine protein/creatinine ratio \>2.0 mg/mg (or \>226.30 mg/mmol)
• Neutrophil count \<1000/microL (or \<1.0 x 109/L)
• Platelet count \<25000/microL (or \<25 x 109/L)
• Hemoglobin \<8 g/dL (or \<80 g/L), or \<7 g/dL (or \<70 g/L) if related to subject's SLE such as in active hemolytic anemia
• Glycosylated hemoglobin (HbA1c) \>8% (or \>0.08) at screening (diabetic subjects only)

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Cardiovascular Diseases

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mariana J Kaplan, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lubna K Hooda, R.N.

CONTACT

(301) 480-1391; lubna.hooda@nih.gov

Mariana J Kaplan, M.D.

CONTACT

(301) 496-0517; mariana.kaplan@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: June 30, 2022
• Study Start: December 7, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 2, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02-10

Locations

US (1)