The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis (NCT07013838) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis
China50 participantsStarted 2025-06-15
Plain-language summary
This is a 24-week, single-center, randomized, open-label trial conducted by Peking Union Medical College Hospital. The aim of this study is to assess the efficacy and safety of deucravacitinib in adult patients with relapsing TAK in comparison to patients treated with TNF inhibitor (TNFi), the most well-recognized therapeutic choice of non-glucocorticoid immunosuppressive for patients with relapsed or refractory TAK.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Signed Written Informed Consent
ā. Participants fully understand the purpose, nature, method, and possible adverse reactions of the study, willing to consent to the trial and follow study protocol and sign informed consent.
ā. Participants must have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before performing any protocol related procedures that are not part of normal patient care.
ā. Type of Participant and Target Disease Characteristics
ā. Adult patients (aged 18 or older) fulfilling the 2022 ACR/EULAR classification criteria for TAK.
ā. Persistence of active disease or relapse despite treatment with GCs combined with a conventional synthetic or biologics immunosuppressive agent other than TNFi.
ā. Active vasculitis by reader interpretation of FDG-PET at enrollment (by the same reader).
ā. Reproductive Status The investigator or designee shall counsel women of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
Exclusion criteria
ā. Medical Conditions
ā. Severe disease from TAK for which urgent treatment with interventional procedures or bypass surgery is considered necessary