[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"large-vessel-vasculitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:large-vessel-vasculitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,73,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100639991","long-axial-field-of-view-lafov-18ffdg-petct-imaging-in-large-vessel-vasculitis-lvv-protocol-optimisation-study-100639991",false,"NCT07628075","Long-Axial Field of View (LAFOV) [18F]FDG PET\u002FCT Imaging in Large Vessel Vasculitis (LVV): Protocol Optimisation Study.","LAVA-FLOW","Inclusion Criteria LVV Patients:\n\n* ≥18 years of age\n* Newly diagnosed LVV (based on the 2022 American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) classification criteria or from a definite diagnosis of LVV on standard of care imaging)\n* WHO performance status 0-2\n* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained\n* eGFR of ≥30 (mL\u002Fmin\u002F1.73m2) within 3 months of \\[18F\\]FDG injection in subjects who have a history of renal impairment, renal disease, renal transplant or diabetes\n\nExclusion Criteria LVV Patients:\n\n* The subject is pregnant or lactating\n* Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure\n* History of allergy to iodinated contrast\n* Commencement of steroids \\> 7 days prior to administration of the radiotracer\n* Poorly controlled diabetic with a blood glucose \\>11mmol\u002FL\n* Evidence of a significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.\n\nInclusion Criteria Healthy Volunteers:\n\n* Three subjects ≥18 years of age that are also \\\u003C 50 years old and three subjects ≥50 years of age\n* WHO performance status 0-2\n* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained\n\nExclusion Criteria Healthy Volunteers:\n\n* The subject is pregnant or lactating\n* Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure\n* Participants with any contra-indication to MRI\n* Known allergy to gadolinium-based contrast agents\n* History of smoking\n* History or current diagnosis of the following medical conditions:\n* Diabetes Mellitus\n* Chronic Kidney Disease\n* Atrial Fibrillation\n* Migraines\n* Rheumatoid Arthritis\n* Systemic Lupus Erythematosus (SLE)\n* Historic or current prescription of the following medications:\n* Any blood pressure medication\n* Any antipsychotic medication\n* Steroids\n* Weight of ≥75Kg (in order to keep the radiation dose \\\u003C10mSV for HV)\n* Evidence of any significant medical condition which, in the opinion of the Investigator, makes it undesirable for the HV to participate in the trial\n* Participants that have undergone any imaging investigation that exposes them to radiation within the previous 12 months",true,"ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"NA","Large vessel vasculitis (LVV) is an autoimmune inflammatory disorder affecting the major arteries of the body. The diagnosis and monitoring this condition can be challenging, as patients often present with symptoms that are unclear, and the diagnostic criteria currently used are varied. Accurate diagnosis is essential because it helps to tailor the treatment to each patient. Some treatments, such as steroids and immunosuppressive medications, can have significant side effects, so they need to be used carefully and only when truly needed.\n\nAn \\[18F\\]FDG Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) involves the injection of a small amount of radiolabelled sugar, which assesses glucose metabolism within the body. \\[18F\\]FDG PET\u002FCT is already used by the NHS to detect inflammation within the vessel walls and diagnose LVV. Current diagnostic criteria for LVV largely rely on visual assessment by a radiologist. This approach therefore has limitations and may not fully capture changes in the levels of inflammation over time.\n\nA new generation of scanners, known as Long Axial Field-of-View (LAFOV)-PET\u002FCT or Total Body PET, are currently transforming what is possible in the field of medical imaging. These LAFOV-PET\u002FCT scanners have new digital detectors that are more sensitive, produce sharper images, and can scan the entire body rapidly. This offers several potential advantages for patients with LVV, including the clearer detection of vessel wall inflammation, the ability to administer lower doses of the radiolabelled sugar (\\[18F\\]FDG), and the ability to take repeated pictures over time to measure subtle changes in blood flow and inflammation. Patients receiving a routine NHS \\[18F\\]FDG PET\u002FCT scan for LVV are typically scanned 60 minutes after injection of the radiotracer using a standard PET\u002FCT. Another benefit of LAFOV-PET\u002FCT scanners is their ability to assess the amount of the radiolabelled sugar taken up by the whole body almost as soon as it is injected which could give important additional information.\n\nAs part of the LAVA-FLOW study we are planning to combine LAFOV-PET\u002FCT with a CT Angiogram (CTA) in patients with LVV. A CTA is a scan that shows doctors what your blood vessels look like. It involves the injection of a dye into a vein that makes your blood vessels visible, highlighting vessel wall inflammation and vessel wall narrowing. This combination of LAFOV-PET\u002FCT and CTA therefore has the potential to give a much more detailed picture of LVV than is achievable using current methods.\n\nThe LAVA-FLOW study therefore aims to develop a standardised protocol to be used in different hospital centres across the UK for the imaging of LVV using LAFOV-PET\u002FCT. We also hope that the results of this particular study could lead to further larger studies with the potential to update the diagnostic criteria and improve the monitoring of this condition.",[27,28,29],"Large Vessel Vasculitis","Takayasu Arteritis","Giant Cell Arteritis (GCA)",[27,31,32,33],"[18F]FDG Long-Axial Field of View (LAFOV)-PET\u002FCT","Angiography","Protocol Optimisation","NOT_YET_RECRUITING","2026-06-01",{"date":37,"type":38},"2026-06-04","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2028-01-01",{"name":44,"class":45},"Imperial College London","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100629678","phase-2-phase-ii-interventional-study-evaluating-efficacy-and-safety-of-secukinumab-in-active-severe-takayasu-patients-100629678","NCT07477795","Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients","Prospective, Bayesian, Randomized, Controlled, Open-label, Parallel-group, Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients","STARS","Inclusion Criteria:\n\n1. Patients ≥15 years\n2. Signed informed consent\n3. Affiliation with the French national social security system.\n4. Adequate and effective contraceptive measures based on CTFG update of recommendations version 1.1 dated 21-Sep-2020\n5. For women of childbearing age, a negative serum or urinary pregnancy test.\n6. Diagnosis of TAK based on the 2022 American College of Rheumatology\u002FEULAR and\u002For Ishikawa criteria modified by Sharma (Appendix 1) for patients with age ≥ 18 years and based the PRINTO\u002FEULAR\u002FPReS criteria for patients with age between 15 and 17 years\n7. Active TAK defined by a National Institutes of Health \\[NIH\\] score \\>1 in the past 2 months (Appendix 2)\n8. Severe TAK, defined as either refractory\u002Frelapsing disease or by the presence of severe arterial involvement at baseline.\n\n   1. refractory\u002Frelapsing disease is defined as the recurrence or persistence of vasculitis activity confirmed by a specialized physician despite adequate corticosteroid tapering (i.e., inability to taper corticosteroids below 1mg\u002Fkg\u002Fday within 1 month due to disease activity, or inability to taper corticosteroids below 10mg\u002Fday within 6 months, or inability to discontinue corticosteroids after 1 year of treatment, or relapse of disease during\u002Fafter gradual decrease of corticosteroids therapy) and\u002For immunosuppressive treatment (e.g., azathioprine, methotrexate, mycophenolate mofetil, leflunomide)\n   2. Severe arterial involvement is defined by the presence of stroke, retinopathy, coronary artery stenosis, pulmonary artery stenosis, mesenteric arteries or celiac trunk stenosis, renal artery stenosis or limb ischemia at baseline.\n9. Patients must be eligible to receive prednisone (or equivalent) 10-50 mg daily at baseline. Oral corticosteroids must be at a stable dose for at least 2 weeks prior to the first administration of study drug at Day 0.\n10. Absence of chronic active infections. Patients with a positive TB test may participate in the study if further work up (according to local practice\u002Fguidelines) conclusively establishes that the patient has no evidence of active tuberculosis. If the test result is indeterminate, the investigator may repeat the test once or may proceed directly to perform the work-up for TB as per local procedure. If presence of latent tuberculosis is established then treatment according to local country guidelines must be initiated prior to randomization\n\nExclusion Criteria:\n\n1. Inability to comply with study guidelines or provide informed consent\n2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.\n\n   Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after stopping of investigational drug. Highly effective contraception methods include:\n   * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptotherma), post- ovulation methods) and withdrawal are not acceptable methods of contraception.\n   * Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n   * Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.\n   * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception.\n\n   In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n   Contraception should be used in accordance with locally approved prescribing information of concomitant medications administered.\n\n   Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered of not child-bearing potential if • they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).\n\n   Sexually active males, unless they agree to use barrier protection during intercourse with a woman of child-bearing potential, while taking study treatment. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended that female partners of male study participants use a second method of birth control.\n\n   Globally, for all sexually active males, contraception should be used in accordance with the locally approved prescribing information of concomitant medications administeredPregnancy or breastfeeding;\n3. History of severe immunosuppression, positive serology for HIV or positive HBsAg\n4. Infection requiring treatment with intravenous antibiotics within 2 weeks prior to the inclusion \\& randomization visit\n5. Contraindication or hypersensitivity to Secukinumab, TNF inhibitors or tocilizumab, corticosteroids, TB prophylactic treatment or to any of their excipients. For contra-indications related to the standard of care medications refer to the summary of each Product Characteristics (SmPC) refer to EMA links (7.1.2)\n6. Have received live vaccines within 3 months prior to inclusion\n7. Indication to initiate infliximab, adalimumab, tocilizumab, secukinumab for another active disease than Takayasu arteritis (retained)\n8. Use of the following systemic treatments during the specified periods\n\n   1. Treatment with biologic therapy secukinumab, within 3 months prior to the inclusion \\& randomization visit\n   2. Treatment with any systemic alkylating agents within 3 months prior to the inclusion \\& randomization visit (e.g., cyclophosphamide, chlorambucil)\n9. Presence of any of the following on-ongoing and on-treatment disease processes (vasculitis and auto- immunes disease):\n\n   Microscopic polyangiitis\n   * Granulomatosis with polyangiitis Eosinophilic granulomatosis with polyangiitis\n   * Polyarteritis nodosa o Cogan's syndrome\n   * Behcet's disease\n   * Kawasaki's disease\n   * Atypical mycobacterial infections\n   * Deep fungal infections o Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis o Cryoglobulinemic vasculitis\n   * Systemic lupus erythematosus\n   * Rheumatoid arthritis o Mixed connective tissue disease or any overlap autoimmune syndrome\n   * Known constitutive immunodeficiency\n10. History of malignancy in the last 5 years (except adequately treated basal or squamous cell carcinoma of the skin)\n11. Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin\u002F1.73m2)\n12. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests such as Aspartate Aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) or serum bilirubin. The investigator should be guided by the following criteria:\n\n    1. SGOT (AST) and SGPT (ALT) may not exceed 3 × the upper limit of normal (ULN). A single parameter elevated up to and including 3 × ULN should be re-checked once more as soon as possible, and in all cases, at least prior to randomization, to rule-out laboratory error.\n    2. Alkaline phosphatase may not exceed 4 × ULN. An elevation up to and including 4 × ULN should be re-checked once more as soon as possible, and in all cases, at least prior to randomization, to rule-out laboratory error.\n    3. Total bilirubin may not exceed 4 × ULN. If the total bilirubin concentration is increased above 4 × ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin\n13. Blood count abnormality:\n\n    1. Platelet count \\\u003C 50 x 10.3\u002Fmm3\n    2. Neutropenia \\\u003C 1000\u002Fmm3\n    3. Haemoglobin \\\u003C 8 g\u002Fdl","15 Years",{"count":57,"type":21},52,[59],"PHASE2","Takayasu's arteritis (TAK) is a large vessel vasculitis preferentially affecting the aorta and its main branches, leading to wall vessels thickening, fibrosis, stenosis, and occlusion. Patients with TAK have a high morbidity rate, 50% will relapse and experience a vascular complication within 10 years from diagnosis. TAK inflammation is mediated by T cells and macrophages. Pro-inflammatory Th1 and Th17 cells are dominant infiltrates in the vascular walls, producing IFN-γ and IL-17 to drive the systemic and vascular manifestations of TAK. Currently, TAK patients are principally treated with non-specific steroids, which are associated with potential side effects, especially when used for a long-time course. Steroid treatment preferentially target innate cytokines, such as IL-1β, IL-12, and IL-6 but have little effect on tissue-residing T cells. Novel approach needs to eliminate all T-cell effectors. The use of classical immunosuppressive drugs (IS) (methotrexate, Leflunomide) and biotherapies are prescribed earlier in the management of the disease in order to improve remission, spare corticosteroids and reduce relapses. Data from observational series report remission in 37-76% of cases with anti TNF alpha and 68% with Tocilizumab. However, a placebo-controlled trial failed to show superiority of tocilizumab in TAK.\n\nTo date, no immunomodulatory treatment has been approved for the management of TAK and corticosteroids sparing remains a major challenge in this disease. Our team has demonstrated the key role of Th1 and Th17 responses in the pathophysiology of TAK. We found that Th17 and Th1 pathways contribute to the systemic and vascular manifestations of TAK and glucocorticoid treatment suppresses Th1 cytokines but spares Th17 cytokines in patients with TAK. Other teams further confirmed the significant increase in Th17 axis in TAK, and its correlation with disease activity, clinical relapse and arterial fibrosis. Secukinumab is a fully human monoclonal antibody that selectively inhibits IL-17A. Secukinumab received approval for adult treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, active non-radiographic axial spondyloarthritis, and active ankylosing spondylitis in numerous countries, including the EU and the USA Recently, a phase II clinical trial assessing the efficacy and safety of secukinumab vs placebo in combination with glucocorticoid taper regimen in giant cell arteritis showed that patients with active giant cell arteritis had a higher sustained remission rate in the secukinumab group than in the placebo group at week 28, and is now being studied in a phase 3 study (NCT04930094).Secukinumab was well tolerated with no new safety concerns. In TAK, recent observational data suggested that secukinumab might be an effective alternative to TNFi in severe TAK patients.\n\nInhibition of IL-17A could represent a potential new therapeutic option for the treatment of severe TAK disease, hence the need for a prospective study to evaluate secukinumab in the management of active severe TAK.",[28,27],[63,27],"Takayasu arteritis","2026-03-23",{"date":66,"type":38},"2026-03-27",{"date":68,"type":21},"2026-04-01",{"date":70,"type":21},"2030-04-01",{"name":72,"class":45},"Assistance Publique - Hôpitaux de Paris",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100584263","phase-2-dapagliflozin-and-endothelin-receptor-antagonism-in-large-vessel-vasculitis-derail-lvv-100584263","NCT06887062","Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)","DERAIL-LVV","Inclusion Criteria:\n\n* A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Active LVV\n* Any organ transplant recipients\n* A requirement for any medications that are contra-indicated whilst taking Bosentan or dapagliflozin\n* Congestive cardiac failure\n* Patients not medically fit to attend study visits\n* Patients without mental capacity or willingness to provide informed consent\n* History of multiple and\u002For severe (clinical judgement as determined by the Investigator) allergic reactions to drugs, including the study drug, or food\n* Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study\n* Participation in another clinical trial for 28 days before or 90 days after the study period",{"count":81,"type":21},60,[59],"Large vessel vasculitis (LVV) is a disease that causes damage to blood vessels. This damage to blood vessels can increase the risk of patients with LVV developing cardiovascular disease, including heart attacks and strokes. A chemical produced in the body called endothelin may contribute to this increase in cardiovascular disease risk by causing the vessels to stiffen and blood pressure to increase.\n\nIt has previously been shown that by blocking the effects of endothelin, vessel stiffness and blood pressure improve. Bosentan is a tablet that blocks the effects of endothelin.\n\nDapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been shown to improve blood vessel function and stiffness in patients with diabetes.\n\nThe investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will be given Bosentan and Dapagliflozin for 6 weeks, followed by Dapagliflozin for 4 weeks, to evaluate their impact on blood vessel function.",[27,29,28],[86,63,87,88,89,90,91,92,93,94],"Large vessel vasculitis","Giant cell arteritis","Endothelin","Bosentan","Inflammation","Endothelial dysfunction","Dual enodthelin receptor antagonism","dapagliflozin","SGLT2 inhibitor","RECRUITING","2026-01-12",{"date":98,"type":38},"2026-01-14",{"date":100,"type":38},"2025-03-21",{"date":102,"type":21},"2027-07-01",{"name":104,"class":45},"University of Edinburgh",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":105},"100579470","prediction-of-risk-of-vascular-structural-damage-in-patients-with-large-vessel-vasculitis-lvv-based-on-petmra-image-evaluation-system-100579470","NCT06824714","Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis (LVV) Based on PET\u002FMRA Image Evaluation System","A Prospective, Observational Study on Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis(LVV) Based on PET\u002FMRA Image Evaluation System","Inclusion Criteria:\n\n1. Clinically suspected or confirmed LVV and willing to undergo PET\u002FMRA\n2. Compliance with long-term follow-up\n3. Sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with other serious cardiovascular and cerebrovascular diseases, malignant tumors, infectious diseases, severe renal insufficiency.\n2. Severe mental disorders, severe claustrophobia unable to cooperate with the examination.\n3. Patients equipped with cardiac pacemaker, artificial heart valve, ferromagnetic vascular clamp after vascular surgery, aneurysm clamp, artificial cochlea, insulin pump and other drug dosage control devices, steel nail plate and other metal internal fixation, artificial joint, electronic eye, artificial eye.\n4. Allergic to contrast medium.\n5. Pregnant or lactating women.\n\nWithdrawal criteria:\n\n1. Any exclusion criteria emerged during patient follow-up.\n2. Voluntarily withdrew from the study.",{"count":114,"type":21},150,"OBSERVATIONAL","Large vessel vasculitis (LVV) causes vascular inflammation, leading to serious complications such as aneurysm formation and stroke. It is difficult to identify the inflammation of the vessel wall by the current imaging methods, thus affecting the timing of treatment and selection of treatment options. Improved examination methods to determine disease activity are highly needed to guide treatment.",[27],[27,119,120,121,122],"PET","MRA","SUVmax","TBA","2025-02-07",{"date":125,"type":38},"2025-02-13",{"date":127,"type":38},"2024-01-01",{"date":129,"type":21},"2028-07-01",{"name":131,"class":45},"Nanjing Medical University"]