Systemic Lupus ErythematosusAISLENCT07913919
Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study
A study testing 68-Gallium Dotatate and Anifrolumab in people with Systemic Lupus Erythematosus and Atherosclerosis Generalized, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Atherosclerosis Generalized
- What is being tested?
- 68-Gallium Dotatate and Anifrolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Nov 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants 18 to 70 years of age
- Able to give written, informed consent and to lie flat for scanning
- Fulfil American College of Rheumatology/European Alliance of Associations for Rheumatology 2019 classification criteria for SLE
- Current antinuclear antibody positive (ANA-ELISA ≥1.0, ANA Hep2 positivity)
- Have ≥4 points on the clinical SLEDAI-2K disease activity score
- Stable standard of care SLE therapies for ≥4 weeks
- Prednisolone dosage ≤7.5 mg (or equivalent) daily
- Up to date on required vaccinations (e.g., pneumonia, varicella zoster, and influenza [inactivated/recombinant]) prior to study entry
Who cannot join
- Women of child-bearing potential not using adequate contraception
- Breastfeeding
- Already taking anifrolumab
- Allergy and/or contraindication to anifrolumab or excipients
- Anaphylaxis to any human gamma globulin therapy
- 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)
Show all 19Show fewer
- 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
- 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
- Any active cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
- Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to signing the ICF
- 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
- Any live or attenuated vaccine within 8 weeks prior to signing the informed consent form (ICF). Administration of killed or subunit vaccines is acceptable
- 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)
- History of active tuberculosis or latent tuberculosis in whom an adequate course of treatment could not be confirmed
- 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)
- Receiving other biological therapies or monoclonal antibodies
- Received rituximab or obinutuzumab within the past 24 weeks
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0BB
Thomas AJ Bond, MBChB, BMedSci, +44 1223 331504, thomas.bond4@nhs.net
Jason M Tarkin, PhD, MBBS, FRCP, jt545@cam.ac.uk
About this study
Official title: 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.
Read the 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.
- Being tested
- 68-Gallium Dotatate, Anifrolumab
- Keywords
- cardio-rheumatology, Atherosclerosis, Lupus, Systemic Lupus Erythematosus, PET, MRI, DOTATATE, Anifrolumab, Interferon
- Medical subject headings
- Lupus Erythematosus, Systemic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-Gallium DotatateDiagnostic test
Patients with active SLE will undergo 68Ga-DOTATATE PET/MRI before and after four months of anifrolumab therapy.
AnifrolumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab arm | Experimental | In this single arm of the study patients with patients will undergoing PET/MRI before and after anifrolumab therapy Receives: Diagnostic Test: 68-Gallium Dotatate; Drug: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of coronary artery 68Ga-DOTATATE maximum tissue-to-blood ratio (TBRmax) after 16 weeks of anifrolumab compared to baseline
Measured: Between baseline and following 16 weeks of anifrolumab therapy
Secondary outcomes (1)
Comparison of ascending aortic 68Ga-DOTATATE TBRmax after 16 weeks of anifrolumab compared to baseline
Measured: Between baseline and 16 weeks of anifrolumab therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start28 Nov 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, AstraZeneca
- Responsible party
- Principal investigator, Jason Tarkin, University of Cambridge
- Investigators
- Jason M Tarkin, PhD MBBS FRCP, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913919
- Sponsor's protocol ID
- A097234
- Acronym
- AISLE
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus (AISLE) Study
- ClinicalTrials.gov ID
- NCT07913919
- Acronym / sponsor ID
- AISLE / A097234
- Keywords
- cardio-rheumatology, Atherosclerosis, Lupus, Systemic Lupus Erythematosus, PET, MRI, DOTATATE, Anifrolumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, AstraZeneca
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab arm | Experimental | Diagnostic Test: 68-Gallium Dotatate, Drug: AnifrolumabIn this single arm of the study patients with patients will undergoing PET/MRI before and after anifrolumab therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants 18 to 70 years of age
- Able to give written, informed consent and to lie flat for scanning
- Fulfil American College of Rheumatology/European Alliance of Associations for Rheumatology 2019 classification criteria for SLE
- Current antinuclear antibody positive (ANA-ELISA ≥1.0, ANA Hep2 positivity)
- Have ≥4 points on the clinical SLEDAI-2K disease activity score
Key exclusion criteria (19 listed)
- Women of child-bearing potential not using adequate contraception
- Breastfeeding
- Already taking anifrolumab
- Allergy and/or contraindication to anifrolumab or excipients
- Anaphylaxis to any human gamma globulin therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68-Gallium DotatatePatients with active SLE will undergo 68Ga-DOTATATE PET/MRI before and after four months of anifrolumab therapy. | Diagnostic test | Anifrolumab arm |
| AnifrolumabPatients 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. | Drug | Anifrolumab arm |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason M Tarkin, PhD MBBS FRCP principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68-Gallium Dotatate and Anifrolumab in people with Systemic Lupus Erythematosus and Atherosclerosis Generalized, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas AJ Bond, MBChB, BMedSci (+44 1223 331504, thomas.bond4@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.