Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study (AISLE)

October 27, 2026 updated by: Jason Tarkin, University of Cambridge

Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus (AISLE) Study

People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation. The aim of this study is to investigate the effects an interferon-targeting drug (anifrolumab) used for the treatment of active SLE on arterial inflammation. Arterial inflammation will be measured at baseline and after 4 months of treatment using Positron Emission Tomography (PET)/ Magnetic Resonance Imaging (MRI) with a radio-labelled tracer (68Ga-DOTATATE). Inflammation assessed by PET/MRI will also be compared with clinical disease activity, inflammatory blood markers and in patients with and without coronary artery disease on computed tomography coronary angiography (CTCA) and/or myocardial involvement on MRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is known that people with SLE are at increased risk of cardiovascular disease because of ongoing inflammation in the body, but the effects of SLE therapies that target inflammation on blood vessels are unknown. Women aged between 35 to 44 are 50 times more likely to have a heart attack than their peers. The risk of stroke, peripheral vascular disease and heart failure is also increased by 2 to 3 fold.

The AISLE study aims to investigate the effects of treating active SLE with an interferon receptor inhibitor (anifrolumab) on arterial inflammation using 68Ga-DOTATATE PET/MRI. Our previous research has shown this imaging method to be effective for tracking macrophage-related arterial inflammation in the cardiovascular system. Patients with active SLE and a clinical SLE Disease Activity Index (SLEDAI) score of ≥4 who meet the eligibility criteria will be invited to participate in the study. All participants will receive anifrolumab therapy in addition to their current SLE treatments, for a total duration of 16 weeks, with imaging performed at baseline and at the end of treatment. CTCA will also be performed, as well as blood sampling for markers of inflammation.

This study will provide valuable information about the effects of anifrolumab on blood vessel inflammation in patients with SLE measured by PET imaging. We expect that this research will also contribute to the wider understanding of how inflammation lowering drugs could be used in general cardiovascular patients to prevent future heart attacks and strokes.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0BB
        • Recruiting
        • Addenbrookes Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female participants 18 to 70 years of age
  2. Able to give written, informed consent and to lie flat for scanning
  3. Fulfil American College of Rheumatology/European Alliance of Associations for Rheumatology 2019 classification criteria for SLE
  4. Current antinuclear antibody positive (ANA-ELISA ≥1.0, ANA Hep2 positivity)
  5. Have ≥4 points on the clinical SLEDAI-2K disease activity score
  6. Stable standard of care SLE therapies for ≥4 weeks
  7. Prednisolone dosage ≤7.5 mg (or equivalent) daily
  8. Up to date on required vaccinations (e.g., pneumonia, varicella zoster, and influenza [inactivated/recombinant]) prior to study entry

Exclusion Criteria:

  1. Women of child-bearing potential not using adequate contraception
  2. Breastfeeding
  3. Already taking anifrolumab
  4. Allergy and/or contraindication to anifrolumab or excipients
  5. Anaphylaxis to any human gamma globulin therapy
  6. History of recurrent infections requiring hospitalisation and intravenous (IV) antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks)
  7. Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, confirmed by (a) HBsAg; or (b) HBcAb and HBV DNA detected above the lower limit of quantitation by reflex testing; or (c) HCV RNA
  8. Any severe case of herpes zoster (HZ) infection, including, but not limited to: (a) systemic HZ such as herpes encephalitis or ophthalmic herpes involving the retina at any time prior to signing the ICF; (b) recurrent cutaneous HZ defined as 2 or more episodes within 2 years prior to signing the ICF; (c) any HZ infection that has not completely resolved within 12 weeks prior to signing the ICF
  9. Any active cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
  10. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to signing the ICF
  11. Any of the following infections: (a) clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc) within 8 weeks prior to signing the ICF (chronic nail infections are allowed); (b) any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF; (c) any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to signing the ICF
  12. Any live or attenuated vaccine within 8 weeks prior to signing the informed consent form (ICF). Administration of killed or subunit vaccines is acceptable
  13. Immunocompromised (known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus)
  14. History of active tuberculosis or latent tuberculosis in whom an adequate course of treatment could not be confirmed
  15. History of cancer (other than squamous or basal cell carcinoma of the skin/cervical cancer in situ treated with curative therapy more than 3 months prior to signing the ICF)
  16. Receiving other biological therapies or monoclonal antibodies
  17. Received rituximab or obinutuzumab within the past 24 weeks
  18. Received belimumab within the past 12 weeks

18. Received cyclophosphamide in the past 6 months 19. Cardiovascular event ≤3 months 20. Contra-indication to MRI or CT scanning 21. Contrast allergy or contrast-nephropathy 22. Active nephritis (>1g protein/24hr or albumin to creatine ratio >100) 23. Active central nervous system lupus 24. Active myocarditis 25. Chronic kidney disease (eGFR <30 mL/min/1.73 m2) 26. Any condition that, in the opinion of the Investigator, would with impact patient safety, ability to complete imaging, or interfere with the interpretation of the study findings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anifrolumab arm

In this single arm of the study patients with patients will undergoing PET/MRI before and after anifrolumab therapy
Diagnostic test: 68-Gallium Dotatate

Patients with active SLE will undergo 68Ga-DOTATATE PET/MRI before and after four months of anifrolumab therapy.

Drug: Anifrolumab

Patients will be treated with anifrolumab for four months to examine the effects of targeting type 1 interferon on inflammation in the cardiovascular system assessed by 68Ga-DOTATATE PET/MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of coronary artery 68Ga-DOTATATE maximum tissue-to-blood ratio (TBRmax) after 16 weeks of anifrolumab compared to baseline
Time Frame: Between baseline and following 16 weeks of anifrolumab therapy
Between baseline and following 16 weeks of anifrolumab therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of ascending aortic 68Ga-DOTATATE TBRmax after 16 weeks of anifrolumab compared to baseline
Time Frame: Between baseline and 16 weeks of anifrolumab therapy
Between baseline and 16 weeks of anifrolumab therapy

Other Outcome Measures

Outcome Measure
Time Frame
Comparison of abdominal aortic and/or renal artery and/or other arterial 68Ga-DOTATATE TBRmax after 16 weeks of anifrolumab compared to baseline
Time Frame: Between baseline and following 16 weeks of anifrolumab therapy
Between baseline and following 16 weeks of anifrolumab therapy
Correlation of arterial 68Ga-DOTATATE TBRmax with clinical disease activity graded by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and/or British Isles Lupus Assessment Group (BILAG)
Time Frame: Between baseline and following 16 weeks of anifrolumab therapy
Between baseline and following 16 weeks of anifrolumab therapy
Correlation of arterial 68Ga-DOTATATE TBRmax with blood markers of systemic inflammation
Time Frame: Between baseline and following 16 weeks of anifrolumab treatment
Between baseline and following 16 weeks of anifrolumab treatment
Comparison of inflammation assessed by 68Ga-DOTATATE PET/MRI (aortic, bone marrow and mediastinal lymph node signals) in patients with coronary artery disease and/or myocardial involvement in SLE versus those without
Time Frame: At baseline - single time point
At baseline - single time point
Comparison of serum lipids at baseline and follow-up
Time Frame: At baseline and following 16 weeks of anifrolumab therapy
At baseline and following 16 weeks of anifrolumab therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

AstraZeneca
Cambridge University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Jason M Tarkin, PhD MBBS FRCP, University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 27, 2026

First Submitted That Met QC Criteria

October 27, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A097234

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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