Baricitinib for Refractory Takayasu Arteritis

NCT06662721 | Completed Phase 2

• 1 other identifier: PKU People's Hospital
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. This study aims to assess the efficacy and safety of Baricitinib in TKA refractory to TNF-α inhibitors.

Conditions

Takayasu Arteritis

Keywords

Takayasu arteritis; Baricitinib

Outcome Measures

Primary Outcomes (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.

  Week 24

Secondary Outcomes (5)

• Changes of National Institutes of Health (NIH) score of patients

  Week 24 and week 48

• Changes of Indian Takayasu Clinical Activity Score (ITAS2010) of patients

  Week 24 and week 48

• Changes of C-reactive protein

  Week 24 and week 48

• Changes of erythrocyte sedimentation rate

  Week 24 and week 48

• Changes of dosage of glucocorticoids from baseline.

  Week 24 and week 48

Study Arms (1)

Treated with baricitinib

EXPERIMENTAL

Ten patients with Takayasu arteritis refractory TNF-α inhibirors were treated with baricitinib.

Drug: Baricitinib 4 MG

Interventions

Baricitinib 4 MG DRUG

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.

Treated with baricitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Liu Tian: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 40411764 DERIVED

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Model Details: Ten patients with Takayasu arteritis refractory to TNF-α inhibitors were treated with baricitinib.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 29, 2024
• Study Start: April 3, 2023
• Primary Completion: December 23, 2023
• Study Completion: June 8, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-09

Locations

CN (1)