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

Takayasu Arteritis (TAK) Clinical Trial

— SELECT-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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04161898
• Other study ID #: M19-052
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 4, 2020
• Est. completion date: August 30, 2027

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Takayasu Arteritis
• Takayasu Arteritis (TAK)

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Argentina	Sanatorio Guemes /ID# 249675	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Italiano La Plata /ID# 249269	La Plata	Buenos Aires
Brazil	CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502	Curitiba	Parana
Brazil	CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517	Juiz de Fora	Minas Gerais
Brazil	LMK Sevicos Medicos S/S /ID# 240645	Porto Alegre	Rio Grande Do Sul
Brazil	SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125	Salvador	Bahia
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 241175	Sao Paulo
Brazil	Hospital do Rim /ID# 240380	Sao Paulo
China	Xuanwu Hospital Capital Medical University /ID# 248104	Beijing
China	Guangdong Provincial People's Hospital /ID# 248350	Guangzhou	Guangdong
China	Zhongshan Hospital Fudan University /ID# 247159	Shanghai
China	The First Hospital of China Medical University /ID# 248107	Shenyang	Liaoning
China	Shenzhen People's Hospital /ID# 248347	Shenzhen	Guangdong
Japan	Juntendo University Hospital /ID# 214292	Bunkyo-ku	Tokyo
Japan	Tokyo Medical And Dental University Hospital /ID# 214138	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 214932	Chiba-shi	Chiba
Japan	St.Luke's International Hospital /ID# 214067	Chuo-ku	Tokyo
Japan	National Hospital Organization Osaka Minami Medical Center /ID# 228779	Kawachinagano Shi	Osaka
Japan	St. Marianna University Hospital /ID# 214535	Kawasaki-shi	Kanagawa
Japan	Kagawa University Hospital /ID# 214776	Kita-gun	Kagawa
Japan	Kyoto University Hospital /ID# 215128	Kyoto-shi	Kyoto
Japan	Maebashi Red Cross Hospital /ID# 230513	Maebashi-shi	Gunma
Japan	Nagano Red Cross Hospital /ID# 214537	Nagano-shi	Nagano
Japan	Nagasaki University Hospital /ID# 215683	Nagasaki-shi	Nagasaki
Japan	Okayama University Hospital /ID# 214499	Okayama-shi	Okayama
Japan	Kindai University Hospital /ID# 216491	Osakasayama-shi	Osaka
Japan	Hokkaido University Hospital /ID# 215066	Sapporo-shi	Hokkaido
Japan	Miyagi Children's Hospital /ID# 248390	Sendai-shi	Miyagi
Japan	Tohoku University Hospital /ID# 214066	Sendai-shi	Miyagi
Japan	Center hospital of the National Center for Global Health and Medicine /ID# 214931	Shinjuku-ku	Tokyo
Japan	Keio University Hospital /ID# 214905	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital /ID# 215129	Shinjuku-ku	Tokyo
Japan	National Cerebral and Cardiovascular Center /ID# 214061	Suita-shi	Osaka
Japan	Ehime University Hospital /ID# 215424	Toon-shi	Ehime
Japan	University of Tsukuba Hospital /ID# 215318	Tsukuba-shi	Ibaraki
Japan	Yokohama City University Hospital /ID# 214345	Yokohama-shi	Kanagawa
Korea, Republic of	Gangnam Severance Hospital /ID# 229543	Seoul
Korea, Republic of	Hanyang University Seoul Hospital /ID# 213842	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 213844	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214566	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 215643	Seoul	Seoul Teugbyeolsi
Turkey	Ankara Univ Medical Faculty /ID# 240015	Ankara
Turkey	Hacettepe University Faculty of Medicine /ID# 239845	Ankara
Turkey	Akdeniz University Faculty /ID# 239847	Antalya
Turkey	Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844	Istanbul
Turkey	Ege University Medical Faculty /ID# 240139	Izmir
Turkey	Necmettin Erbakan Universitesi /ID# 239848	Meram Konya

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Argentina,  Brazil,  China,  Japan,  Korea, Republic of,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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.	Up to occurrence of 40 events (approximately 52 months)
Secondary	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).	Up to occurrence of 40 events (approximately 52 months)

External Links

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