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.
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
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
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
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
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
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
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
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.
- Conditions
- Takayasu Arteritis (TAK)
- 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 group | Role | What they receive |
|---|---|---|
| Arm 2: Placebo for Upadacitinib | Experimental | Participants will be administered placebo once daily (QD) along with prednisolone. Receives: Drug: Upadacitinib; Drug: Placebo for Upadacitinib; Drug: Prednisolone |
| Arm 1: Upadacitinib | Experimental | Participants 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.
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)
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)
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)
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.
- First posted13 Nov 2019
- Study start4 Feb 2020
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu Arteritis (TAK)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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.