Takayasu Arteritis (TAK)Phase 4NCT07013838
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis
A Phase 4 study testing Deucravacitinib and Adalimumab in people with Takayasu Arteritis (TAK), run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takayasu Arteritis (TAK)
- What is being tested?
- Deucravacitinib and Adalimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 31 Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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
- Adult patients (aged 18 or older) fulfilling the 2022 ACR/EULAR classification criteria for TAK.
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- Persistence of active disease or relapse despite treatment with GCs combined with a conventional synthetic or biologics immunosuppressive agent other than TNFi.
- Active vasculitis by reader interpretation of FDG-PET at enrollment (by the same reader).
- 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.
- WOCBP must have a negative highly sensitive specify: urine or serum as required by local regulations pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study intervention.
- A female is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
- Is not a WOCBP OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the intervention period and for at least 5 half-lives after product administration and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
- WOCBP and male participants who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- 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
- Malignancy in the past 5 years (with the exception of fully excised non-melanoma skin cancer or cervical carcinoma in situ)
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- Physical and Laboratory Test Findings
- Serum liver enzyme tests 3 times higher than the upper limits of normal range
- Estimated glomerular filtration rate ≤ 30 ml/minute
- Other Exclusion Criteria
- Females who are pregnant
- Ever treated with TNFi (including adalimumab) and discontinued due to inadequate response or intolerance.
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Xinping Tian, MD, 86-13691165939, tianxp6@126.com
Shangyi Jin, MD, 86-13671049688, jinshangyi@pumch.cn
About this study
Official title: Comparison of Deucravacitinib and Adalimumab for the Treatment of Relapsed Takayasu's Arteritis: The TYK-TAK 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.
Read the detailed description
Background:
The majority of patients with TAK experience relapses, and some patients fail to respond adequately to current medications used for treatment of TAK. There is an urgent unmet need to identify novel therapies to effectively treat TAK. Th-17 and Th-1 cells, and their related cytokines IL-12, IL-23, IL-17, and type I interferon have all been reported to play a role in the pathogenesis of TAK. Tyrosine kinase 2 (TYK2) mediates signaling transduction between these key cytokines and immune cells. Therefore, blocking TYK2 signaling may downregulate potential pathogenic pathways in TAK, and may be a therapeutic alternative. No study has investigated the effectiveness of agents targeting TYK2 in the treatment of TAK so far. In the present study, we aim to investigate whether deucravacitinib, an oral, selective, allosteric inhibitor of TYK2, is effective and safe for patients with relapsed TAK.
Objectives:
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.
Overall Design:
This is a 24-week, single-center, randomized, open-label trial conducted by Peking Union Medical College Hospital. Patients enrolled into the study are randomly assigned (in a 1:1 ratio, 25 patients in each group) to receive deucravacitinib or adalimumab (a TNFi). Patients are followed for efficacy and safety at month 1, month 3, and month 6. Adverse events/Serious adverse events are assessed and recorded at each visit.
- Conditions
- Takayasu Arteritis (TAK)
- Being tested
- Deucravacitinib, Adalimumab
- Keywords
- Deucravacitinib, Adalimumab, Relapsed, Efficacy, Safety, Takayasu arteritis
- Medical subject headings
- Takayasu Arteritis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Deucravacitinib 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.
AdalimumabDrug
TNFα 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.
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib treatment group | Experimental | Patients randomly assigned to the deucravacitinib treatment group are required to take the deucravacitinib tablets 6mg orally once daily on an empty stomach or after a meal during D1-D168, and orally take the study drug deucravacitinib with warm water. It is forbidden to drink water from 1 h before administration to 1 h after administration (except for administration of water) and fasting within 1 h after administration. Continuous treatment for 168 days or subject discontinuation criteria were met. The time of dose administration is called "0" hour. Subjects who miss a study medication on one day are not allowed to take a supplement to compensate but should take the next dose. Receives: Drug: Deucravacitinib |
| Adalimumab treatment group | Active comparator | Participants assigned to the adalimumab treatment group receive adalimumab 40mg by subcutaneous injection every 2 weeks during D1-D168. Adalimumab is administered for 24 weeks unless the discontinuation criteria are met. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- ESR <20mm/hour;
- CRP <10mg/L;
- No progression of vessel damage in Doppler ultrasonography or CTA, including no new or worsening mural thickness, or stenosis or dilatation;
- 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:
- ESR <40mm/hour or decrease by 50% compared to the baseline value;
- CRP <20mg/L or decrease by 50% compared to the baseline value;
- 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
Measured: Week 24
Secondary outcomes (8)
Time to clinical remission
time from the baseline to achieve clinical remission
Measured: from inclusion to the end of the study, 24 weeks in total
Disease recurrence after achieving clinical remission
recurrence rate after achieving clinical remission
Measured: from inclusion to the end of the study, 24 weeks in total
Time to disease recurrence
time from clinical remission to disease recurrence
Measured: from inclusion to the end of the study, 24 weeks in total
Changes in erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR) is an indicator of systemic inflammation, will be reported in mm/h.
Measured: week 4, 12 and 24
Changes in serum C reactive protein (CRP)
serum C reactive protein (CRP) is an indicator of systemic inflammation, will be reported in mg/L
Measured: week 4, 12 and 24
Changes in vascular ultrasonography
Vascular Doppler ultrasonography of the carotid arteries, subclavian arteries and abdominal aorta
Measured: from baseline to weeks 12 and 24
Changes in PET/CT scans
PET-CT, including 18F-FDG PET/CT and 68Ga-FAPI PET/CT are performed at baseline and at the end of the study to assess the status of arterial inflammation and fibrosis.
Measured: from the baseline to week 24
Change in level of cytokines
A cytokine panel are used to evaluate serum levels of cytokines in involved signaling pathways.
Measured: week 4, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takayasu Arteritis (TAK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, single-center, randomized, open-label trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinping Tian, Chinese SLE Treatment And Research Group
- Investigators
- Xinping Tian, MD, Principal investigator, Peking Unione Mdecial College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013838
- Sponsor's protocol ID
- TYK2-TAK-01
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only patient's clincial information could be released to public
Publications
Le AM, Puig L, Torres T. Deucravacitinib for the Treatment of Psoriatic Disease. Am J Clin Dermatol. 2022 Nov;23(6):813-822. doi: 10.1007/s40257-022-00720-0. Epub 2022 Aug 12.
PubMed 35960487