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Takayasu ArteritisPhase 2NCT06662721

Baricitinib for Refractory Takayasu Arteritis

A Phase 2 study testing Baricitinib 4 MG in people with Takayasu Arteritis, run by Liu Tian at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches. For TKA refractory to TNF-α, Baricitinib, a reversible inhibitor of Janus kinases (JAK) family members JKA1 and JAK2, represents a potential treatment option. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Takayasu Arteritis
What is being tested?
Baricitinib 4 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
3 Apr 2023to 8 Jun 2024
Phase
Phase 2
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

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 12 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.
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  • 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.
  • 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

Other trials in China

About this study

Official title: Baricitinib for Takayasu Arteritis Refractory to TNF-α Inhibitors: a Prospective Pilot Open-label Study

Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches. For TKA refractory to TNF-α, Baricitinib, a reversible inhibitor of Janus kinases (JAK) family members JKA1 and JAK2, represents a potential treatment option. This study aims to assess the efficacy and safety of Baricitinib in TKA refractory to TNF-α inhibitors.

Read the detailed description

This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of baricitinib in Takayasu arteritis (TKA) refractory to TNF-α inhibitors. 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 baricitinib at 4 mg/day for up to 48 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.

Being tested
Baricitinib 4 MG
Keywords
Takayasu arteritis, Baricitinib
Medical subject headings
Takayasu Arteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baricitinib 4 MGDrug

    The patients received Baricitinib for 48 weeks. The method is to take Baricitinib 4mg every day for a period of 48 weeks. All the patients will be followed up prospectively for 48 weeks.

Study groups in NCT06662721
Study groupRoleWhat they receive
Treated with baricitinibExperimentalTen patients with Takayasu arteritis refractory TNF-α inhibirors were treated with baricitinib.
Receives: Drug: Baricitinib 4 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Week 24

Secondary outcomes (5)

  1. Changes of National Institutes of Health (NIH) score of patients

    The manifestations, imaging findings and laboratory parametes were recorded during the follow-up. The disease activity of patients were accessed by National Institutes of Health (NIH) score. (Range: 0~4, higher scores mean higher disease activity)

    Measured: Week 24 and week 48

  2. Changes of Indian Takayasu Clinical Activity Score (ITAS2010) of patients

    The manifestations, imaging findings and laboratory parameters were recorded during the follow-up. The disease activity of patients were accessed by Indian Takayasu Clinical Activity Score (ITAS2010). (Range: 0~51, higher scores mean higher disease activity)

    Measured: Week 24 and week 48

  3. Changes of C-reactive protein

    Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.

    Measured: Week 24 and week 48

  4. Changes of erythrocyte sedimentation rate

    Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.

    Measured: Week 24 and week 48

  5. Changes of dosage of glucocorticoids from baseline.

    The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.

    Measured: Week 24 and week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start3 Apr 2023
  3. Primary completion23 Dec 2023
  4. Study completion8 Jun 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Ten patients with Takayasu arteritis refractory to TNF-α inhibitors were treated with baricitinib.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06662721
Sponsor's protocol ID
PKU People's Hospital
Status last verified
Sep 2024
First submitted
18 Sep 2024
Last updated
29 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li J, Xia W, Ji H, Gong X, Dong Q, Wu Y, Wang L, Peng M, Liu J, Ma K, Yu Q, Cui X, Luo Y, Zhu W, Zhang S, Chen S, Li Y, Li Z, Liu T. Baricitinib for Takayasu arteritis refractory to TNF-alpha inhibitors: a multicentre, single-arm trial. Rheumatology (Oxford). 2025 Oct 1;64(10):5262-5268. doi: 10.1093/rheumatology/keaf286.

    PubMed 40411764

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Baricitinib 4 MG in people with 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 5 inclusion and 13 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 29 Oct 2024. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06662721, which also lists 1 linked publication.

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 29 Oct 2024.

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