An interventional study of 68-Gallium Dotatate and Anifrolumab in Systemic Lupus Erythematosus and Atherosclerosis Generalized, sponsored by University of Cambridge. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Cambridge · Not applicable, Interventional, and Diagnostic
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.
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.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 15 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →University of Cambridge is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 ( \<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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this single arm of the study patients with patients will undergoing PET/MRI before and after anifrolumab therapy
Diagnostic Test: 68-Gallium Dotatate · Drug: Anifrolumab
Patients with active SLE will undergo 68Ga-DOTATATE PET/MRI before and after four months of anifrolumab therapy.
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.
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
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
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
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
Correlation of arterial 68Ga-DOTATATE TBRmax with blood markers of systemic inflammation
Time frame: 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
Comparison of serum lipids at baseline and follow-up
Time frame: At baseline and following 16 weeks of anifrolumab therapy
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Anifrolumab
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