Takayasu ArteritisNCT07500467
Upadacitinib for Refractory Takayasu Arteritis
An observational study of Takayasu Arteritis, run by Liu Tian at 1 site in China.
Trial summary
Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches.Upadacitinib is an oral, selective JAK1 inhibitor that potently inhibits JAK1 activity, representing a potential therapeutic option.This study aims to assess the efficacy and safety of upadacitinib in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Takayasu Arteritis
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2024to 1 Feb 2026
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Based on the inclusion and exclusion criteria, adult patients with refractory TAK admitted to Peking University People's Hospital and other hospitals were selected, and clinical and laboratory indicators during the same period were collected.
Who may be able to join
- Male or female aged 18-70 years at time of screening. Diagnosis of Takayasu arteritis (according to the 2022 ACR/EULAR) for ≥3 months before screening.
- Active Takayasu arteritis at time of screening (NIH score≥2). Resistant to traditional therapies and anti-TNF-α therapy for at least 6 months.
- Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- TKA-related active major organ involvement requiring immunosuppressive therapy, e.g., pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis).
- High-dose glucocorticoid (>1mg/kg/d) usage within 1 month. Severe comorbidities: including heart failure (≥ grade III NYHA), renal insufficiency (creatinine clearance ≤30 ml/min), hepatic insufficiency (serum ALT or AST >3 times the ULN, or total bilirubin >ULN for the central laboratory conducting the test). Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- Known allergies, hypersensitivity, or intolerance to Baricitinib or its excipients.
- Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
- Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
- Infected with HIV (positive serology for HIV antibody) or hepatitis C (positive serology for Hep C antibody). If seropositive, consultation with a physician with expertise in the treatment of HIV or hepatitis C virus infection was recommended.
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- Infected with hepatitis B virus. For patients who were not eligible for this study due to hepatitis B virus test results, consultation with a physician with expertise in the treatment of hepatitis B virus infection was recommended.
- Had any known malignancy or has a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that had been treated with no evidence of recurrence for ≥3 months before the first study agent administration or cervical neoplasia with surgical cure).
- Had uncontrolled psychiatric or emotional disorder, including a history of drug and alcohol abuse within the past 3 years that might prevent the successful completion of the study.
- Received, or was expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study agent, during the study, or within 4 months after the last administration of study agent. Had a BCG vaccination within 12 months of screening.
- Pregnancy, lactation or women of child-bearing potential (WCBP) unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
- Men whose partners are of child-bearing potential but who are unwilling to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality
About this study
Official title: Analysis of the Efficacy and Safety of Upadacitinib in the Treatment of Refractory Takayasu Arteritis
Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches.Upadacitinib is an oral, selective JAK1 inhibitor that potently inhibits JAK1 activity, representing a potential therapeutic option.This study aims to assess the efficacy and safety of upadacitinib in refractory Takayasu arteritis.
Read the detailed description
This is a single-arm trial conducted to evaluate the safety and efficacy of upadacitinib in refractory Takayasu arteritis (TKA). Patients in active TKA and unresponsive to at least 6 months of TNF-α inhibitors therapy were enrolled. Patients discontinued TNF-α inhibitors and received upadacitinib at 15 mg/day for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
- Conditions
- Takayasu Arteritis
- Medical subject headings
- Takayasu Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients achieving complete remission and partial remission
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
Measured: 24 weeks
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start19 Mar 2024
- Primary completion31 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu ArteritisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Liu Tian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Tian, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500467
- Sponsor's protocol ID
- PKU People's Hospital .
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy and Safety of Upadacitinib in the Treatment of Refractory Takayasu Arteritis
- ClinicalTrials.gov ID
- NCT07500467
- Acronym / sponsor ID
- PKU People's Hospital .
- Conditions
- Takayasu Arteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Liu TianUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches.Upadacitinib is an oral, selective JAK1 inhibitor that potently inhibits JAK1 activity, representing a potential therapeutic option.This study aims to assess the efficacy and safety of upadacitinib in refractory Takayasu arteritis.
Detailed description
This is a single-arm trial conducted to evaluate the safety and efficacy of upadacitinib in refractory Takayasu arteritis (TKA). Patients in active TKA and unresponsive to at least 6 months of TNF-α inhibitors therapy were enrolled. Patients discontinued TNF-α inhibitors and received upadacitinib at 15 mg/day for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on the inclusion and exclusion criteria, adult patients with refractory TAK admitted to Peking University People's Hospital and other hospitals were selected, and clinical and laboratory indicators during the same period were collected.
Key inclusion criteria (3 listed)
- Male or female aged 18-70 years at time of screening. Diagnosis of Takayasu arteritis (according to the 2022 ACR/EULAR) for ≥3 months before screening.
- Active Takayasu arteritis at time of screening (NIH score≥2). Resistant to traditional therapies and anti-TNF-α therapy for at least 6 months.
- Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (12 listed)
- TKA-related active major organ involvement requiring immunosuppressive therapy, e.g., pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis).
- High-dose glucocorticoid (>1mg/kg/d) usage within 1 month. Severe comorbidities: including heart failure (≥ grade III NYHA), renal insufficiency (creatinine clearance ≤30 ml/min), hepatic insufficiency (serum ALT or AST >3 times the ULN, or total bilirubin >ULN for the central laboratory conducting the test). Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- Known allergies, hypersensitivity, or intolerance to Baricitinib or its excipients.
- Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
- Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients achieving complete remission and partial remission
Time frame: 24 weeks
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu Arteritis, run by Liu Tian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients achieving complete remission and partial remission (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.