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Takayasu Arteritis (TAK)Phase 3SELECT-TAKNCT04161898

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

A Phase 3 study testing Upadacitinib and Prednisolone in people with Takayasu Arteritis (TAK), run by AbbVie at 48 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Takayasu Arteritis (TAK)
What is being tested?
Upadacitinib and Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
48 sitesin 6 countries
Study dates
4 Feb 2020to Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 6 countries.

48 sites in 6 countries

Japan23 sites

  • Juntendo University Hospital /ID# 214292

    Bunkyo-ku, Tokyo, 113-8431

  • Institute of Science Tokyo Hospital /ID# 214138

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital /ID# 214932

    Chiba, Chiba, 260-8677

  • St. Lukes International Hospital /ID# 214067

    Chuo-ku, Tokyo, 104-8560

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

    Kawachinagano Shi, Osaka, 586-8521

  • St Marianna University School Of Medicine /ID# 214535

    Kawasaki-shi, Kanagawa, 216-8511

  • Kagawa University Hospital /ID# 214776

    Kita-gun, Kagawa-ken, 761-0793

  • Duplicate_Kyoto University Hospital /ID# 215128

    Kyoto, Kyoto, 606-8507

  • Maebashi Red Cross Hospital /ID# 230513

    Maebashi, Gunma, 371-0811

  • Nagano Red Cross Hospital /ID# 214537

    Nagano, Nagano, 380-8582

  • Duplicate_Nagasaki University Hospital /ID# 215683

    Nagasaki, Nagasaki, 852-8501

  • Okayama University Hospital /ID# 214499

    Okayama, Okayama-ken, 700-8558

  • Kindai University Hospital /ID# 216491

    Sakai-shi, Osaka, 590-0197

  • Duplicate_Hokkaido University Hospital /ID# 215066

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 214066

    Sendai, Miyagi, 9808574

  • Miyagi Children's Hospital /ID# 248390

    Sendai, Miyagi, 989-3126

  • Duplicate_Keio University Hospital /ID# 214905

    Shinjuku-ku, Tokyo, 160-8582

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

    Shinjuku-ku, Tokyo, 162-8655

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

    Shinjuku-ku, Tokyo, 162-8666

  • National Cerebral and Cardiovascular Center /ID# 214061

    Suita-shi, Osaka, 564-8565

  • Ehime University Hospital /ID# 215424

    Toon-shi, Ehime, 791-0295

  • University of Tsukuba Hospital /ID# 215318

    Tsukuba, Ibaraki, 305-8576

  • Yokohama City University Hospital /ID# 214345

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Turkey (Türkiye)7 sites

  • Hacettepe University Faculty of Medicine /ID# 239845

    Ankara, 06100

  • Ankara Univ Medical Faculty /ID# 240015

    Ankara, 06590

  • Akdeniz University Faculty /ID# 239847

    Antalya, 06100

  • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846

    Istanbul, 34480

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

    Istanbul, 34899

  • Ege University Medical Faculty /ID# 240139

    Izmir, 35040

  • Necmettin Erbakan Universitesi /ID# 239848

    Meram Konya, 42080

Other trials in Turkey (Türkiye)

Brazil6 sites

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

    Curitiba, Paraná, 80030-110

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

    Juiz de Fora, Minas Gerais, 36010-570

  • LMK Sevicos Medicos S/S /ID# 240645

    Porto Alegre, Rio Grande do Sul, 90480-000

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

    Salvador, Estado de Bahia, 40150-150

  • Hospital do Rim /ID# 240380

    São Paulo, 04038-002

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

    São Paulo, 05403-000

Other trials in Brazil

China5 sites

  • Xuanwu Hospital Capital Medical University /ID# 248104

    Beijing, Beijing Municipality, 100053

  • Guangdong Provincial Peoples Hospital /ID# 248350

    Guangzhou, Guangdong, 510080

  • Zhongshan Hospital Fudan University /ID# 247159

    Shanghai, Shanghai Municipality, 200032

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

    Shenyang, Liaoning, 110001

  • Shenzhen People's Hospital /ID# 248347

    Shenzhen, Guangdong, 518020

Other trials in China

South Korea5 sites

  • Seoul National University Hospital /ID# 213844

    Seoul, Seoul Teugbyeolsi, 03080

  • Hanyang University Seoul Hospital /ID# 213842

    Seoul, Seoul Teugbyeolsi, 04763

  • Gangnam Severance Hospital /ID# 229543

    Seoul, Seoul Teugbyeolsi, 06273

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

    Seoul, Seoul Teugbyeolsi, 06591

  • Yonsei University Health System Severance Hospital /ID# 215643

    Seoul, 03722

Other trials in South Korea

Argentina2 sites

  • Fundación Sanatorio Guemes /ID# 249675

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1180

  • Hospital Italiano La Plata /ID# 249269

    La Plata, Buenos Aires, 1900

Other trials in Argentina

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu)

The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.

Being tested
Upadacitinib, Placebo for Upadacitinib, Prednisolone
Keywords
Takayasu Arteritis (TAK), Upadacitinib, Placebo, Corticosteroid, Prednisolone
Medical subject headings
Takayasu Arteritis

What participants receive

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

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Upadacitinib will be administered as oral tablet

  • Placebo for UpadacitinibDrug

    Placebo for upadacitinib will be administered as oral tablet

  • PrednisoloneDrug

    Prednisolone will be administered as oral tablet

Study groups in NCT04161898
Study groupRoleWhat they receive
Arm 2: Placebo for UpadacitinibExperimentalParticipants will be administered placebo once daily (QD) along with prednisolone.
Receives: Drug: Upadacitinib; Drug: Placebo for Upadacitinib; Drug: Prednisolone
Arm 1: UpadacitinibExperimentalParticipants will be administered updadacitinib once daily (QD) along with prednisolone.
Receives: Drug: Upadacitinib; Drug: Prednisolone

What is being measured

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

  1. Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period

    Relapse of TAK is defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms OR where the criteria are met based on one category per protocol definition of relapse of TAK.

    Measured: Up to occurrence of 40 events (approximately 52 months)

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 58 months

Secondary outcomes (2)

  1. Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period

    Kerr criteria for relapse are defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective or subjective systemic symptoms, elevated inflammation markers, vascular or ischemic signs and symptoms, or worsening in imaging assessment due to TAK.

    Measured: Up to occurrence of 40 events (approximately 52 months)

  2. Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period

    Imaging with computed tomography angiogram (CTA).

    Measured: Up to occurrence of 40 events (approximately 52 months)

Timeline

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

  1. First posted13 Nov 2019
  2. Study start4 Feb 2020
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04161898
Sponsor's protocol ID
M19-052
Acronym
SELECT-TAK
Status last verified
Feb 2026
First submitted
12 Nov 2019
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib and Prednisolone in people with Takayasu Arteritis (TAK), run by AbbVie at 48 sites in 6 countries.

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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Japan, Turkey (Türkiye), Brazil, China, South Korea and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period (time frame: Up to occurrence of 40 events (approximately 52 months)). 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?

On the ClinicalTrials.gov record for NCT04161898.

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 18 Feb 2026.

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