NCT07913919 Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study
| NCT ID | NCT07913919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cambridge |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-11-28 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Jason M Tarkin, PhD MBBS FRCP
PRINCIPAL INVESTIGATOR
University of Cambridge
Frequently Asked Questions
Who can join the NCT07913919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07913919 currently recruiting?
Yes, NCT07913919 is actively recruiting participants. Contact the research team at thomas.bond4@nhs.net for enrollment information.
Where is the NCT07913919 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT07913919 clinical trial?
NCT07913919 is sponsored by University of Cambridge. The principal investigator is Jason M Tarkin, PhD MBBS FRCP at University of Cambridge. The trial plans to enroll 15 participants.
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