A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
SELECT-TAK
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)
1 other identifier
interventional
56
6 countries
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2020
Longer than P75 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
February 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
February 18, 2026
February 1, 2026
8.5 years
November 12, 2019
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to occurrence of 40 events (approximately 52 months)
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.
Up to approximately 58 months
Secondary Outcomes (2)
Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period
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
Up to occurrence of 40 events (approximately 52 months)
Study Arms (2)
Arm 2: Placebo for Upadacitinib
EXPERIMENTALParticipants will be administered placebo once daily (QD) along with prednisolone.
Arm 1: Upadacitinib
EXPERIMENTALParticipants will be administered updadacitinib once daily (QD) along with prednisolone.
Interventions
Upadacitinib will be administered as oral tablet
Prednisolone will be administered as oral tablet
Placebo for upadacitinib will be administered as oral tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (48)
Fundación Sanatorio Guemes /ID# 249675
Ciudad Autonoma Buenos Aires, Buenos Aires, 1180, Argentina
Hospital Italiano La Plata /ID# 249269
La Plata, Buenos Aires, 1900, Argentina
SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
Salvador, Estado de Bahia, 40150-150, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
Juiz de Fora, Minas Gerais, 36010-570, Brazil
CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
Curitiba, Paraná, 80030-110, Brazil
LMK Sevicos Medicos S/S /ID# 240645
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Hospital do Rim /ID# 240380
São Paulo, 04038-002, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175
São Paulo, 05403-000, Brazil
Xuanwu Hospital Capital Medical University /ID# 248104
Beijing, Beijing Municipality, 100053, China
Guangdong Provincial Peoples Hospital /ID# 248350
Guangzhou, Guangdong, 510080, China
Shenzhen People's Hospital /ID# 248347
Shenzhen, Guangdong, 518020, China
First Affiliated Hospital of China Medical University /ID# 248107
Shenyang, Liaoning, 110001, China
Zhongshan Hospital Fudan University /ID# 247159
Shanghai, Shanghai Municipality, 200032, China
Chiba University Hospital /ID# 214932
Chiba, Chiba, 260-8677, Japan
Ehime University Hospital /ID# 215424
Toon-shi, Ehime, 791-0295, Japan
Maebashi Red Cross Hospital /ID# 230513
Maebashi, Gunma, 371-0811, Japan
Duplicate_Hokkaido University Hospital /ID# 215066
Sapporo, Hokkaido, 060-8648, Japan
University of Tsukuba Hospital /ID# 215318
Tsukuba, Ibaraki, 305-8576, Japan
Kagawa University Hospital /ID# 214776
Kita-gun, Kagawa-ken, 761-0793, Japan
St Marianna University School Of Medicine /ID# 214535
Kawasaki-shi, Kanagawa, 216-8511, Japan
Yokohama City University Hospital /ID# 214345
Yokohama, Kanagawa, 236-0004, Japan
Duplicate_Kyoto University Hospital /ID# 215128
Kyoto, Kyoto, 606-8507, Japan
Tohoku University Hospital /ID# 214066
Sendai, Miyagi, 9808574, Japan
Miyagi Children's Hospital /ID# 248390
Sendai, Miyagi, 989-3126, Japan
Nagano Red Cross Hospital /ID# 214537
Nagano, Nagano, 380-8582, Japan
Duplicate_Nagasaki University Hospital /ID# 215683
Nagasaki, Nagasaki, 852-8501, Japan
Okayama University Hospital /ID# 214499
Okayama, Okayama-ken, 700-8558, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 228779
Kawachinagano Shi, Osaka, 586-8521, Japan
Kindai University Hospital /ID# 216491
Sakai-shi, Osaka, 590-0197, Japan
National Cerebral and Cardiovascular Center /ID# 214061
Suita-shi, Osaka, 564-8565, Japan
Juntendo University Hospital /ID# 214292
Bunkyo-ku, Tokyo, 113-8431, Japan
Institute of Science Tokyo Hospital /ID# 214138
Bunkyo-ku, Tokyo, 113-8519, Japan
St. Lukes International Hospital /ID# 214067
Chuo-ku, Tokyo, 104-8560, Japan
Duplicate_Keio University Hospital /ID# 214905
Shinjuku-ku, Tokyo, 160-8582, Japan
National Center for Global Health and Medicine /ID# 214931
Shinjuku-ku, Tokyo, 162-8655, Japan
Duplicate_Tokyo Women's Medical University Hospital /ID# 215129
Shinjuku-ku, Tokyo, 162-8666, Japan
Seoul National University Hospital /ID# 213844
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Hanyang University Seoul Hospital /ID# 213842
Seoul, Seoul Teugbyeolsi, 04763, South Korea
Gangnam Severance Hospital /ID# 229543
Seoul, Seoul Teugbyeolsi, 06273, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Yonsei University Health System Severance Hospital /ID# 215643
Seoul, 03722, South Korea
Hacettepe University Faculty of Medicine /ID# 239845
Ankara, 06100, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 240015
Ankara, 06590, Turkey (Türkiye)
Akdeniz University Faculty /ID# 239847
Antalya, 06100, Turkey (Türkiye)
Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846
Istanbul, 34480, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty /ID# 240139
Izmir, 35040, Turkey (Türkiye)
Necmettin Erbakan Universitesi /ID# 239848
Meram Konya, 42080, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 13, 2019
Study Start
February 4, 2020
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.