Secukinumab for Takayasu arteritis

Inclusion criteria

• {"criterion_text":"- Patients ≥15 years and\tSigned informed consent"}
• {"criterion_text":"- Affiliation with the French national social security system. Patients with AME are eligible"}
• {"criterion_text":"- Adequate and effective contraceptive measures based on CTFG update of recommendations version 1.1 dated 21-Sep-2020"}
• {"criterion_text":"- For women of childbearing age, a negative serum or urinary pregnancy test"}
• {"criterion_text":"- Diagnosis of TAK based on the 2022 American College of Rheumatology/EULAR and/or Ishikawa criteria modified by Sharma"}
• {"criterion_text":"- Active TAK defined by a National Institutes of Health [NIH] score >1 in the past 2 months"}
• {"criterion_text":"- Severe TAK, defined as either refractory/relapsing disease or by the presence of severe arterial involvement at baseline"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Absence of chronic active infections. Patients with a positive TB test may participate in the study if further work up (according to local practice/guidelines) conclusively establishes that the patient has no evidence of active tuberculosis"}

Exclusion criteria

• {"criterion_text":"- Inability to comply with study guidelines or provide informed consent"}
• {"criterion_text":"- Blood count abnormality: a.\tPlatelet count < 50 x 10.3/mm3 b.\tNeutropenia < 1000/mm3 c.\tHaemoglobin < 8 g/dl c.\tHémoglobine < 8 g/dl"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- History of severe immunosuppression, positive serology for HIV or positive HBsAg"}
• {"criterion_text":"- Infection requiring treatment with intravenous antibiotics within 2 weeks prior to the inclusion & randomization visit"}
• {"criterion_text":"- Contraindication or hypersensitivity to Secukinumab, TNF inhibitors or tocilizumab, corticosteroids, TB prophylactic treatment or to any of their excipients"}
• {"criterion_text":"- Have received live vaccines within 3 months prior to inclusion"}
• {"criterion_text":"- History of malignancy in the last 5 years (except adequately treated basal or squamous cell carcinoma of the skin)"}
• {"criterion_text":"- Severe renal impairment (creatinine clearance <30mL/min/1.73m2)"}
• {"criterion_text":"- 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: a.\tSGOT (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. b.\tAlkaline 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. c.\tTotal 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"}

Primary endpoints

• {"endpoint_text":"- Disease remission (defined by NIH score ≤ 1) at 6 months and with prednisone discontinuation Disease activity is measured according to National Institutes of Health (NIH) criteria (Kerr 1994) and comprises four variables, each scoring one point as below (scale range 0-4 points). A score equal or superior to 2 is considered as active disease.","definition_or_measurement_approach":"Disease activity measured according to National Institutes of Health (NIH) criteria (Kerr 1994). Remission defined by NIH score ≤ 1 at 6 months together with prednisone discontinuation."}
• {"endpoint_text":"- \tCriterion 1 scores if at least one of the following systemic characteristics, without any other cause identified: o\tConstitutional symptoms such as low-grade fever, weight loss and fatigue; o\tExtra-vascular manifestations (e.g., polyarthralgia / arthritis, erythema nodosum, episcleritis, etc).","definition_or_measurement_approach":"Criterion 1 is presence of at least one listed systemic characteristic with no other cause identified; part of NIH activity scoring."}
• {"endpoint_text":"- \tCriterion 2 scores if at least one of the following clinical signs have appeared since the previous visit: o\tNew carotidodynia, vascular claudication or pain along an arterial pathway o\tNew transient ischemic attack (TIA), stroke, acute coronary syndrome or instable angina o\tNew pulse loss o\tNew vascular bruit o\tNew anisotension","definition_or_measurement_approach":"Criterion 2 is presence of at least one listed new clinical sign since previous visit; part of NIH activity scoring."}
• {"endpoint_text":"- \tCriterion 3 scores if at least one of the following biological inflammatory markers are elevated in the absence of any other reason: o\tErythrocyte sedimentation rate at 1 hour > 30 mm/h ; o\tC-reactive protein > 10 mg/L ; o\tFibrinogen > 4 g/L.","definition_or_measurement_approach":"Criterion 3 is elevation of at least one specified inflammatory biomarker in absence of other cause; part of NIH activity scoring."}
• {"endpoint_text":"- \tCriterion 4 scores if at least one of the following radiological signs appears in a otherwise unaffected arterial territory: o\tNew arterial wall thickening with wall contrast enhancement in vascular imaging Appearance of new vascular lesions (e.g., New arterial wall thickening stenosis, aneurysms) in Doppler, MRA, computed tomography angiography (CTA) or new hypermetabolism in 18-Fluorodeoxyglucose positron emission tomography/computed tomography (18-FDG-PET).","definition_or_measurement_approach":"Criterion 4 is presence of at least one listed radiological sign (new arterial wall changes or lesions on Doppler, MRA, CTA or new FDG-PET hypermetabolism); part of NIH activity scoring."}

Secondary endpoints

• {"endpoint_text":"- Cumulative incidence of relapse over the 12 months after initiation of experimental treatment","definition_or_measurement_approach":"Relapse defined by NIH criteria (NIH score ≥2); cumulative incidence measured over 12 months after treatment start."}
• {"endpoint_text":"- Cumulative incidence of treatment failure over the 12 months after initiation of experimental therapy","definition_or_measurement_approach":"Treatment failure defined as disease persistently active as per NIH criteria (NIH score ≥2); cumulative incidence over 12 months."}
• {"endpoint_text":"- Cumulative prednisone dose over the 12 months after initiation of experimental treatment","definition_or_measurement_approach":"Cumulative prednisone dose recorded over 12 months following treatment initiation."}
• {"endpoint_text":"- Glucocorticoid-free disease remission will be assessed at 3, 6, and 12 months using the primary composite endpoint","definition_or_measurement_approach":"Assessment of remission without glucocorticoids at specified timepoints using the primary composite NIH-based endpoint."}
• {"endpoint_text":"- Cumulative incidence of AE and SAE over the 12 months after initiation of investigational therapy","definition_or_measurement_approach":"Adverse events and serious adverse events collected and cumulative incidence calculated over 12 months."}
• {"endpoint_text":"- Change in the Physical Component Summary (PCS) of the SF36 between the start of experimental treatment,6 and 12 months after","definition_or_measurement_approach":"Change in SF-36 Physical Component Summary score from baseline to 6 and 12 months."}
• {"endpoint_text":"- Change in vascular lesions at 3, 6, and 12 months after the start of experimental treatment, measured by angio CT and/or magnetic resonance imaging angiography and/or Doppler","definition_or_measurement_approach":"Radiological assessment (angio CT, MRA and/or Doppler) comparing vascular lesions at baseline and 3/6/12 months."}
• {"endpoint_text":"- Change in vascular hypermetabolism at 6 and 12 months after the start of experimental treatment, measured by 18-FDG-PET","definition_or_measurement_approach":"18-FDG-PET imaging to assess changes in vascular hypermetabolism at 6 and 12 months compared to baseline."}
• {"endpoint_text":"- Cumulative incidence of revascularization procedures (endovascular or surgical) required because of disease at 6 and 12 months after initiation of experimental therapy.","definition_or_measurement_approach":"Recording of revascularization procedures (endovascular or surgical) required due to disease; cumulative incidence at 6 and 12 months."}

France

Earliest CTIS Part Ii Submission Date

14-01-2026

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

57

Number Of Sites

18

Number Of Participants

52

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"NOVARTIS","duties_or_roles":"Source of monetary support","organisation_type":""}