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New drug aims to tame rare artery disease

NCT ID NCT04161898

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether upadacitinib (Rinvoq) can help people with Takayasu arteritis, a rare disease that inflames large arteries. About 56 adults who have had a recent relapse despite steroids will receive either upadacitinib or a placebo, along with a steroid taper. The main goal is to see if the drug delays or prevents another relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (Rinvoq)
What this could lead to
If successful, this could offer a new treatment option to control Takayasu arteritis and reduce reliance on steroids.
What could go wrong
This is a relatively small phase 3 trial, and the drug may not prevent relapses better than placebo. Upadacitinib also carries risks like infections and allergic reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 56 people

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

Started

Feb 2020

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

15 years and older

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: * Participants must be at least 18 years of age (at least 15 years of age in Japan) * Clinical diagnosis of TAK and fulfilling the Japanese Guidelines for Management of Vasculitis Syndrome 2017 criteria. * Participant must have experienced a relapse of TAK within 12 weeks of Baseline despite being on treatment with oral corticosteroid. * Participants must be in remission and on a stable corticosteroid dose prior to Baseline. Exclusion Criteria: * Treatment with an interleukin-6 (IL-6) inhibitor or Janus Kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib) within 4 weeks of Baseline. * Current use of immunomodulators other than corticosteroids.

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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)

Contacts and locations

Locations

  • Akdeniz University Faculty /ID# 239847

    Antalya, 06100, Turkey (Türkiye)

  • Ankara Univ Medical Faculty /ID# 240015

    Ankara, 06590, Turkey (Türkiye)

  • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846

    Istanbul, 34480, Turkey (Türkiye)

  • CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502

    Curitiba, Paraná, 80030-110, Brazil

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • Chiba University Hospital /ID# 214932

    Chiba, Chiba, 260-8677, Japan

  • Duplicate_Hokkaido University Hospital /ID# 215066

    Sapporo, Hokkaido, 060-8648, Japan

  • Duplicate_Keio University Hospital /ID# 214905

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Duplicate_Kyoto University Hospital /ID# 215128

    Kyoto, Kyoto, 606-8507, Japan

  • Duplicate_Nagasaki University Hospital /ID# 215683

    Nagasaki, Nagasaki, 852-8501, Japan

  • Duplicate_Tokyo Women's Medical University Hospital /ID# 215129

    Shinjuku-ku, Tokyo, 162-8666, Japan

  • Ege University Medical Faculty /ID# 240139

    Izmir, 35040, Turkey (Türkiye)

  • Ehime University Hospital /ID# 215424

    Toon-shi, Ehime, 791-0295, Japan

  • First Affiliated Hospital of China Medical University /ID# 248107

    Shenyang, Liaoning, 110001, China

  • Fundación Sanatorio Guemes /ID# 249675

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1180, Argentina

  • Gangnam Severance Hospital /ID# 229543

    Seoul, Seoul Teugbyeolsi, 06273, South Korea

  • Guangdong Provincial Peoples Hospital /ID# 248350

    Guangzhou, Guangdong, 510080, China

  • Hacettepe University Faculty of Medicine /ID# 239845

    Ankara, 06100, Turkey (Türkiye)

  • Hanyang University Seoul Hospital /ID# 213842

    Seoul, Seoul Teugbyeolsi, 04763, South Korea

  • Hospital Italiano La Plata /ID# 249269

    La Plata, Buenos Aires, 1900, Argentina

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175

    São Paulo, 05403-000, Brazil

  • Hospital do Rim /ID# 240380

    São Paulo, 04038-002, Brazil

  • Institute of Science Tokyo Hospital /ID# 214138

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Juntendo University Hospital /ID# 214292

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kagawa University Hospital /ID# 214776

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Kindai University Hospital /ID# 216491

    Sakai-shi, Osaka, 590-0197, Japan

  • LMK Sevicos Medicos S/S /ID# 240645

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • Maebashi Red Cross Hospital /ID# 230513

    Maebashi, Gunma, 371-0811, Japan

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844

    Istanbul, 34899, Turkey (Türkiye)

  • Miyagi Children's Hospital /ID# 248390

    Sendai, Miyagi, 989-3126, Japan

  • Nagano Red Cross Hospital /ID# 214537

    Nagano, Nagano, 380-8582, Japan

  • National Center for Global Health and Medicine /ID# 214931

    Shinjuku-ku, Tokyo, 162-8655, Japan

  • National Cerebral and Cardiovascular Center /ID# 214061

    Suita-shi, Osaka, 564-8565, Japan

  • National Hospital Organization Osaka Minami Medical Center /ID# 228779

    Kawachinagano Shi, Osaka, 586-8521, Japan

  • Necmettin Erbakan Universitesi /ID# 239848

    Meram Konya, 42080, Turkey (Türkiye)

  • Okayama University Hospital /ID# 214499

    Okayama, Okayama-ken, 700-8558, Japan

  • SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Seoul National University Hospital /ID# 213844

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shenzhen People's Hospital /ID# 248347

    Shenzhen, Guangdong, 518020, China

  • St Marianna University School Of Medicine /ID# 214535

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • St. Lukes International Hospital /ID# 214067

    Chuo-ku, Tokyo, 104-8560, Japan

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • Tohoku University Hospital /ID# 214066

    Sendai, Miyagi, 9808574, Japan

  • University of Tsukuba Hospital /ID# 215318

    Tsukuba, Ibaraki, 305-8576, Japan

  • Xuanwu Hospital Capital Medical University /ID# 248104

    Beijing, Beijing Municipality, 100053, China

  • Yokohama City University Hospital /ID# 214345

    Yokohama, Kanagawa, 236-0004, Japan

  • Yonsei University Health System Severance Hospital /ID# 215643

    Seoul, 03722, South Korea

  • Zhongshan Hospital Fudan University /ID# 247159

    Shanghai, Shanghai Municipality, 200032, China

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