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New drug combo aims to tame rare artery disease

NCT ID NCT07451665

Disease control Sponsor: Chinese SLE Treatment And Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two new drugs, vunakizumab and ivarmacitinib, for people with active Takayasu arteritis (TAK), a rare disease that causes inflammation in large blood vessels. The trial will enroll 180 adults aged 18-70 whose disease is still active despite standard treatments. Researchers will compare the drugs' ability to control the disease over 52 weeks, aiming to reduce reliance on steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * a. Adult patients (aged between 18-70 years) fulfilling the 2022 ACR/EULAR classification criteria for TAK with new-onset or relapsing disease. * b. Presence of active disease despite treatment with gluccorticoids combined with a conventional synthetic or biologic immunosuppressive agent other than JAK inhibitors and IL-17 inhibitors, including new-onset patients and relapsed patients. Patient is considered to have active disease by the investigator is the patients meets at least two of the following three criteria: i) one or more clinical manifestations determined by the investigator to be due to active TAK; ii) one or more findings on imaging of progressive disease; or iii) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Clinical criteria included constitutional symptoms (fever, fatigue, and weight loss), musculoskeletal symptoms, vascular pain, neurological or visual symptoms, abdominal pain or angina, new or worsening limb claudication, loss of pulses, and worsening hypertension. Imaging criteria includes new vascular stenosis or aneurysms detected by ultrasound, computed tomography angiography (CTA), or magnetic resonance angiography. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: 1. Medical Conditions 1. Severe disease from TAK for which urgent treatment with interventional vascular procedures or bypass surgery is considered necessary 2. Critical organ involvement of TAK, such as myocardial or coronary artery involvement, or cerebral ischemia, that is anticipated to need treatment during the study 3. Active hepatitis B or C virus infection 4. Active tuberculosis (Patients with latent tuberculosis infection could be enrolled with preventive therapy for tuberculosis flare) 5. Malignancy in the past 5 years (with the exception of fully excised non-melanoma skin cancer or cervical carcinoma in situ) 6. Poorly controlled diabetes 7. Patients with history of venous thrombosis 8. Upper GI bleeding within 3 months prior to enrollment 9. Uncontrolled heart failure 10. Refractory hypertension 2. Abnormal Laboratory Test Findings k. Serum liver enzyme elevation 3 times higher than the upper limits of normal range l. Severe renal function impairment with estimated glomerular filtration rate ≤ 30 ml/minute/1.73 m2, calculated using the Modification of Diet in Renal Disease equation (doi:10.1056/NEJMoa2102953) 3. Other Exclusion Criteria m. Females who are pregnant or intend to be pregnant during the time frame of the study n. History of treatment with JAKi or IL-17i. o. Any other medical, psychiatric, and/or social reason as determined by the investigator to be a contraindication for study participation

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Conditions

The condition(s) this trial relates to.

Takayasu arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Takayasu arteritis (TAK)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital Capital Medical University

    Beijing, Beijing Municipality, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • Jiaozuo People's Hospital

    Jiaozuo, Henan, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, China

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Neimenggu, China

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Neimenggu, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guanzhou, Guangdong, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Hospital of Jilin University

    Ch’ang-ch’un, Jilin, China

  • The First Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, China

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