The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis
ConditionTakayasu Arteritis (TAK)
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Deucravacitinib
DrugDeucravacitinib is a new, oral, selective, allosteric inhibitor of TYK2. It was first approved in the United States on 09-Sep-2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Adalimumab
DrugTNFα inhibitors have already been used in TAK treatment. Several retrospective studies have demonstrated the treatment effects of these agents in patients with TAK, including disease remission, GC tapering and vascular inflammation control. According to the ACR and EULAR guidelines, TNFis are recommended to be considered in cases of relapsing or refractory TAK. These agents (including adalimumab) are the most frequently analyzed therapeutic modalities in recent studies of TAK.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Deucravacitinib treatment groupExperimental treatment 1 intervention
Group B: Adalimumab treatment groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate at week 24
* Overall response is defined as the combination of both complete and partial responses. * Complete (treatment) response is defined as the absence or complete resolution of clinical signs and symptoms of active TAK and a patient achieving all of the following: 1. ESR \<20mm/hour; 2. CRP \<10mg/L; 3. No progression of vessel damage in Doppler ultrasonography or CTA, including no new or worsening mural thickness, or stenosis or dilatation; 4. Dose of GC \<15 mg/day prednisone (or equivalent dosage of other GCs). * Partial (treatment) response is defined as the absence or complete resolution of clinical signs and symptoms of active TAK and: 1. ESR \<40mm/hour or decrease by 50% compared to the baseline value; 2. CRP \<20mg/L or decrease by 50% compared to the baseline value; 3. fulfilling the other two criteria of complete response. * The absence or complete resolution of clinical signs and symptoms of active TAK is a pre-required criterion for both complete and partial
Time frame
Week 24Secondary outcomes
1
Time to clinical remission
time from the baseline to achieve clinical remission
Time frame
from inclusion to the end of the study, 24 weeks in total2
Disease recurrence after achieving clinical remission
recurrence rate after achieving clinical remission
Time frame
from inclusion to the end of the study, 24 weeks in total3
Time to disease recurrence
time from clinical remission to disease recurrence
Time frame
from inclusion to the end of the study, 24 weeks in total4
Changes in erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR) is an indicator of systemic inflammation, will be reported in mm/h.
Time frame
week 4, 12 and 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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