A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
NCT ID: NCT04161898
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
56 participants
INTERVENTIONAL
2020-02-04
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Upadacitinib
Participants will be administered updadacitinib once daily (QD) along with prednisolone.
Upadacitinib
Upadacitinib will be administered as oral tablet
Prednisolone
Prednisolone will be administered as oral tablet
Arm 2: Placebo for Upadacitinib
Participants will be administered placebo once daily (QD) along with prednisolone.
Upadacitinib
Upadacitinib will be administered as oral tablet
Placebo for Upadacitinib
Placebo for upadacitinib will be administered as oral tablet
Prednisolone
Prednisolone will be administered as oral tablet
Interventions
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Upadacitinib
Upadacitinib will be administered as oral tablet
Placebo for Upadacitinib
Placebo for upadacitinib will be administered as oral tablet
Prednisolone
Prednisolone will be administered as oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Current use of immunomodulators other than corticosteroids.
15 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Fundación Sanatorio Guemes /ID# 249675
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Italiano La Plata /ID# 249269
La Plata, Buenos Aires, Argentina
SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
Salvador, Estado de Bahia, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
Juiz de Fora, Minas Gerais, Brazil
CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
Curitiba, Paraná, Brazil
LMK Sevicos Medicos S/S /ID# 240645
Porto Alegre, Rio Grande do Sul, Brazil
Hospital do Rim /ID# 240380
São Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175
São Paulo, , Brazil
Xuanwu Hospital Capital Medical University /ID# 248104
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital /ID# 248350
Guangzhou, Guangdong, China
Shenzhen People's Hospital /ID# 248347
Shenzhen, Guangdong, China
The First Hospital of China Medical University /ID# 248107
Shenyang, Liaoning, China
Zhongshan Hospital Fudan University /ID# 247159
Shanghai, Shanghai Municipality, China
Chiba University Hospital /ID# 214932
Chiba, Chiba, Japan
Ehime University Hospital /ID# 215424
Toon-shi, Ehime, Japan
Maebashi Red Cross Hospital /ID# 230513
Maebashi, Gunma, Japan
Duplicate_Hokkaido University Hospital /ID# 215066
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital /ID# 215318
Tsukuba, Ibaraki, Japan
Kagawa University Hospital /ID# 214776
Kita-gun, Kagawa-ken, Japan
St Marianna University School Of Medicine /ID# 214535
Kawasaki-shi, Kanagawa, Japan
Yokohama City University Hospital /ID# 214345
Yokohama, Kanagawa, Japan
Duplicate_Kyoto University Hospital /ID# 215128
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 214066
Sendai, Miyagi, Japan
Miyagi Children's Hospital /ID# 248390
Sendai, Miyagi, Japan
Nagano Red Cross Hospital /ID# 214537
Nagano, Nagano, Japan
Duplicate_Nagasaki University Hospital /ID# 215683
Nagasaki, Nagasaki, Japan
Okayama University Hospital /ID# 214499
Okayama, Okayama-ken, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 228779
Kawachinagano Shi, Osaka, Japan
Kindai University Hospital /ID# 216491
Osakasayama-shi, Osaka, Japan
National Cerebral and Cardiovascular Center /ID# 214061
Suita-shi, Osaka, Japan
Juntendo University Hospital /ID# 214292
Bunkyo-ku, Tokyo, Japan
Institute of Science Tokyo Hospital /ID# 214138
Bunkyo-ku, Tokyo, Japan
St.Luke's International Hospital /ID# 214067
Chuo-ku, Tokyo, Japan
Duplicate_Keio University Hospital /ID# 214905
Shinjuku-ku, Tokyo, Japan
Center hospital of the National Center for Global Health and Medicine /ID# 214931
Shinjuku-ku, Tokyo, Japan
Duplicate_Tokyo Women's Medical University Hospital /ID# 215129
Shinjuku-ku, Tokyo, Japan
Seoul National University Hospital /ID# 213844
Seoul, Seoul Teugbyeolsi, South Korea
Hanyang University Seoul Hospital /ID# 213842
Seoul, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital /ID# 229543
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 215643
Seoul, , South Korea
Hacettepe University Faculty of Medicine /ID# 239845
Ankara, , Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 240015
Ankara, , Turkey (Türkiye)
Akdeniz University Faculty /ID# 239847
Antalya, , Turkey (Türkiye)
Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty /ID# 240139
Izmir, , Turkey (Türkiye)
Necmettin Erbakan Universitesi /ID# 239848
Meram Konya, , Turkey (Türkiye)
Countries
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Related Links
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Other Identifiers
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M19-052
Identifier Type: -
Identifier Source: org_study_id
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