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

February 16, 2026 updated by: AbbVie

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1180
        • Fundación Sanatorio Guemes /ID# 249675
      • La Plata, Buenos Aires, Argentina, 1900
        • Hospital Italiano La Plata /ID# 249269
  • Brazil
      • São Paulo, Brazil, 04038-002
        • Hospital do Rim /ID# 240380
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 240645
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital Capital Medical University /ID# 248104
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital /ID# 248350
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital /ID# 248347
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • First Affiliated Hospital of China Medical University /ID# 248107
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital Fudan University /ID# 247159
  • Japan
    • Chiba
      • Chiba, Chiba, Japan, 260-8677
        • Chiba University Hospital /ID# 214932
    • Ehime
      • Toon-shi, Ehime, Japan, 791-0295
        • Ehime University Hospital /ID# 215424
    • Gunma
      • Maebashi, Gunma, Japan, 371-0811
        • Maebashi Red Cross Hospital /ID# 230513
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Duplicate_Hokkaido University Hospital /ID# 215066
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital /ID# 215318
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Kagawa University Hospital /ID# 214776
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • St Marianna University School Of Medicine /ID# 214535
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital /ID# 214345
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Duplicate_Kyoto University Hospital /ID# 215128
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 214066
      • Sendai, Miyagi, Japan, 989-3126
        • Miyagi Children's Hospital /ID# 248390
    • Nagano
      • Nagano, Nagano, Japan, 380-8582
        • Nagano Red Cross Hospital /ID# 214537
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Duplicate_Nagasaki University Hospital /ID# 215683
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital /ID# 214499
    • Osaka
      • Kawachinagano Shi, Osaka, Japan, 586-8521
        • National Hospital Organization Osaka Minami Medical Center /ID# 228779
      • Sakai-shi, Osaka, Japan, 590-0197
        • Kindai University Hospital /ID# 216491
      • Suita-shi, Osaka, Japan, 564-8565
        • National Cerebral and Cardiovascular Center /ID# 214061
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 214292
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Institute of Science Tokyo Hospital /ID# 214138
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St. Lukes International Hospital /ID# 214067
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Duplicate_Keio University Hospital /ID# 214905
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Duplicate_Tokyo Women's Medical University Hospital /ID# 215129
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • National Center for Global Health and Medicine /ID# 214931
  • South Korea
      • Seoul, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 215643
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 213844
      • Seoul, Seoul Teugbyeolsi, South Korea, 04763
        • Hanyang University Seoul Hospital /ID# 213842
      • Seoul, Seoul Teugbyeolsi, South Korea, 06273
        • Gangnam Severance Hospital /ID# 229543
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Faculty of Medicine /ID# 239845
      • Ankara, Turkey (Türkiye), 06590
        • Ankara Univ Medical Faculty /ID# 240015
      • Antalya, Turkey (Türkiye), 06100
        • Akdeniz University Faculty /ID# 239847
      • Istanbul, Turkey (Türkiye), 34480
        • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846
      • Istanbul, Turkey (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty /ID# 240139
      • Meram Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan Universitesi /ID# 239848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Upadacitinib
Participants will be administered updadacitinib once daily (QD) along with prednisolone.
Drug: Upadacitinib
Upadacitinib will be administered as oral tablet
Other Names:
  • RINVOQ
  • ABT-494
Drug: Prednisolone
Prednisolone will be administered as oral tablet
Experimental: Arm 2: Placebo for Upadacitinib
Participants will be administered placebo once daily (QD) along with prednisolone.
Drug: Upadacitinib
Upadacitinib will be administered as oral tablet
Other Names:
  • RINVOQ
  • ABT-494
Drug: Prednisolone
Prednisolone will be administered as oral tablet
Drug: Placebo for Upadacitinib
Placebo for upadacitinib will be administered as oral tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
Up to occurrence of 40 events (approximately 52 months)
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 58 months
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.
Up to approximately 58 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period
Time Frame: Up to occurrence of 40 events (approximately 52 months)
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.
Up to occurrence of 40 events (approximately 52 months)
Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period
Time Frame: Up to occurrence of 40 events (approximately 52 months)
Imaging with computed tomography angiogram (CTA).
Up to occurrence of 40 events (approximately 52 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M19-052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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