Clinical trial NCT04161898: A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Takayasu Arteritis (TAK)
Keywords: Takayasu Arteritis (TAK)
Upadacitinib
Placebo
Corticosteroid
Prednisolone
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 56
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period
timeFrame: Up to occurrence of 40 events (approximately 52 months)
Secondary outcomes:
measure: Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period
timeFrame: Up to occurrence of 40 events (approximately 52 months)
measure: Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period
timeFrame: Up to occurrence of 40 events (approximately 52 months)
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Hospital Italiano La Plata /ID# 249269
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Sanatorio Guemes /ID# 249675
state: Ciudad Autonoma De Buenos Aires
city: Salvador
country: Brazil
facility: SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
state: Bahia
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
state: Minas Gerais
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
state: Parana
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 240645
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Hospital do Rim /ID# 240380
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 248350
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital /ID# 248347
state: Guangdong
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University /ID# 248104
state: Guizhou
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 248107
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University /ID# 247159
state: Shanghai
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 214932
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 215424
state: Ehime
city: Maebashi-shi
country: Japan
facility: Maebashi Red Cross Hospital /ID# 230513
state: Gunma
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 215066
state: Hokkaido
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 215318
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital /ID# 214776
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital /ID# 214535
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital /ID# 214345
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 215128
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 214066
state: Miyagi
city: Sendai-shi
country: Japan
facility: Miyagi Children's Hospital /ID# 248390
state: Miyagi
city: Nagano-shi
country: Japan
facility: Nagano Red Cross Hospital /ID# 214537
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 215683
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 214499
state: Okayama
city: Kawachinagano Shi
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center /ID# 228779
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 216491
state: Osaka
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center /ID# 214061
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 214292
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital /ID# 214138
state: Tokyo
city: Chuo-ku
country: Japan
facility: St.Luke's International Hospital /ID# 214067
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 214905
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Center hospital of the National Center for Global Health and Medicine /ID# 214931
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 215129
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 213844
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 213842
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 229543
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 215643
city: Antalya
country: Turkey
facility: Akdeniz University Faculty /ID# 239847
state: Adana
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 240139
state: Adana
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine /ID# 239845
city: Ankara
country: Turkey
facility: Ankara Univ Medical Faculty /ID# 240015
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844
city: Meram Konya
country: Turkey
facility: Necmettin Erbakan Universitesi /ID# 239848
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: