The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

NCT07013838 | Not Yet Recruiting Phase 4

• 1 other identifier: TYK2-TAK-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Takayasu Arteritis (TAK)

Keywords

Deucravacitinib; Adalimumab; Relapsed; Efficacy; Safety; Takayasu arteritis

Outcome Measures

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

  Week 24

Secondary Outcomes (8)

• Time to clinical remission

  from inclusion to the end of the study, 24 weeks in total

• Disease recurrence after achieving clinical remission

  from inclusion to the end of the study, 24 weeks in total

• Time to disease recurrence

  from inclusion to the end of the study, 24 weeks in total

• Changes in erythrocyte sedimentation rate (ESR)

  week 4, 12 and 24

• Changes in serum C reactive protein (CRP)

  week 4, 12 and 24

Study Arms (2)

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.

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.

Drug: Adalimumab

Interventions

Deucravacitinib DRUG

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.

Deucravacitinib treatment group

Adalimumab DRUG

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.

Adalimumab treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 35960487 BACKGROUND

MeSH Terms

Conditions

Takayasu Arteritis; Recurrence

Interventions

deucravacitinib; Adalimumab

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xinping Tian, MD

  Peking Unione Mdecial College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shangyi Jin, MD

CONTACT

86+13671049688; jinshangyi@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: prospective, single-center, randomized, open-label trial

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 10, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)