The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese SLE Treatment And Research Group

About this trial

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.

Eligibility criteria

Qualifiers

Signed Written Informed Consent

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.

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.

Type of Participant and Target Disease Characteristics

Disqualifiers

Medical Conditions

Severe disease from TAK for which urgent treatment with interventional procedures or bypass surgery is considered necessary

Critical organ involvement of TAK, such as myocardial or coronary artery involvement, or cerebral ischemia

Active hepatitis B or C virus infection, active tuberculosis infection

Trial design

Treatments tested in this trial

  • Deucravacitinib
  • Adalimumab

Treatment groups

50 Participants
are divided into 2 treatment groups