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STARS (Secukinumab in TAkayasu ARteritiS)
EU CTIS ID: 2024-516215-24-00
What this study is testing
To evaluate disease remission (defined by a NIH score ≤ 1) at 6 months in severe TAK patients and with discontinuation of prednisone
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥15 years and Signed informed consent
- Affiliation with the French national social security system. Patients with AME are eligible
- Adequate and effective contraceptive measures based on CTFG update of recommendations version 1.1 dated 21-Sep-2020
- For women of childbearing age, a negative serum or urinary pregnancy test
- Diagnosis of TAK based on the 2022 American College of Rheumatology/EULAR and/or Ishikawa criteria modified by Sharma
- Active TAK defined by a National Institutes of Health [NIH] score >1 in the past 2 months
You likely can't join if
- Inability to comply with study guidelines or provide informed consent
- Blood count abnormality: a. Platelet count < 50 x 10.3/mm3 b. Neutropenia < 1000/mm3 c. Haemoglobin < 8 g/dl c. Hémoglobine < 8 g/dl
- Pregnancy or breastfeeding
- History of severe immunosuppression, positive serology for HIV or positive HBsAg
- Infection requiring treatment with intravenous antibiotics within 2 weeks prior to the inclusion & randomization visit
- Contraindication or hypersensitivity to Secukinumab, TNF inhibitors or tocilizumab, corticosteroids, TB prophylactic treatment or to any of their excipients
See the full eligibility criteria
- Patients ≥15 years and Signed informed consent
- Affiliation with the French national social security system. Patients with AME are eligible
- Adequate and effective contraceptive measures based on CTFG update of recommendations version 1.1 dated 21-Sep-2020
- For women of childbearing age, a negative serum or urinary pregnancy test
- Diagnosis of TAK based on the 2022 American College of Rheumatology/EULAR and/or Ishikawa criteria modified by Sharma
- Active TAK defined by a National Institutes of Health [NIH] score >1 in the past 2 months
- Severe TAK, defined as either refractory/relapsing disease or by the presence of severe arterial involvement at baseline
- 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.
- 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
- Inability to comply with study guidelines or provide informed consent
- Blood count abnormality: a. Platelet count < 50 x 10.3/mm3 b. Neutropenia < 1000/mm3 c. Haemoglobin < 8 g/dl c. Hémoglobine < 8 g/dl
- Pregnancy or breastfeeding
- History of severe immunosuppression, positive serology for HIV or positive HBsAg
- Infection requiring treatment with intravenous antibiotics within 2 weeks prior to the inclusion & randomization visit
- Contraindication or hypersensitivity to Secukinumab, TNF inhibitors or tocilizumab, corticosteroids, TB prophylactic treatment or to any of their excipients
- Have received live vaccines within 3 months prior to inclusion
- History of malignancy in the last 5 years (except adequately treated basal or squamous cell carcinoma of the skin)
- Severe renal impairment (creatinine clearance <30mL/min/1.73m2)
- 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. 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. b. 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. c. 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.