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

Primary Purpose

Takayasu Arteritis (TAK)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo for Upadacitinib
Prednisolone
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu Arteritis (TAK) focused on measuring Takayasu Arteritis (TAK), Upadacitinib, Placebo, Corticosteroid, Prednisolone

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Italiano La Plata /ID# 249269Recruiting
  • Sanatorio Guemes /ID# 249675Recruiting
  • SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125Recruiting
  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517Recruiting
  • CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502Recruiting
  • LMK Sevicos Medicos S/S /ID# 240645Recruiting
  • Hospital do Rim /ID# 240380Recruiting
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 241175Recruiting
  • Guangdong Provincial People's Hospital /ID# 248350Recruiting
  • Shenzhen People's Hospital /ID# 248347Recruiting
  • The First Hospital of China Medical University /ID# 248107Recruiting
  • Xuanwu Hospital Capital Medical University /ID# 248104Recruiting
  • Zhongshan Hospital Fudan University /ID# 247159Recruiting
  • Chiba University Hospital /ID# 214932Recruiting
  • Ehime University Hospital /ID# 215424Recruiting
  • Maebashi Red Cross Hospital /ID# 230513Recruiting
  • Hokkaido University Hospital /ID# 215066Recruiting
  • University of Tsukuba Hospital /ID# 215318Recruiting
  • Kagawa University Hospital /ID# 214776Recruiting
  • St. Marianna University Hospital /ID# 214535Recruiting
  • Yokohama City University Hospital /ID# 214345Recruiting
  • Kyoto University Hospital /ID# 215128Recruiting
  • Tohoku University Hospital /ID# 214066Recruiting
  • Miyagi Children's Hospital /ID# 248390Recruiting
  • Nagano Red Cross Hospital /ID# 214537Recruiting
  • Nagasaki University Hospital /ID# 215683Recruiting
  • Okayama University Hospital /ID# 214499Recruiting
  • National Hospital Organization Osaka Minami Medical Center /ID# 228779Recruiting
  • Kindai University Hospital /ID# 216491Recruiting
  • National Cerebral and Cardiovascular Center /ID# 214061Recruiting
  • Juntendo University Hospital /ID# 214292Recruiting
  • Tokyo Medical And Dental University Hospital /ID# 214138Recruiting
  • St.Luke's International Hospital /ID# 214067Recruiting
  • Keio University Hospital /ID# 214905Recruiting
  • Center Hospital of the National Center for Global Health and Medicine /ID# 214931Recruiting
  • Tokyo Women's Medical University Hospital /ID# 215129Recruiting
  • Yonsei University Health System Severance Hospital /ID# 215643Recruiting
  • Hanyang University Seoul Hospital /ID# 213842Recruiting
  • Seoul National University Hospital /ID# 213844Recruiting
  • Gangnam Severance Hospital /ID# 229543Recruiting
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214566Recruiting
  • Hacettepe University Faculty of Medicine /ID# 239845Recruiting
  • Ankara Univ Medical Faculty /ID# 240015Recruiting
  • Akdeniz University Faculty /ID# 239847Recruiting
  • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846Recruiting
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844Recruiting
  • Ege University Medical Faculty /ID# 240139Recruiting
  • Necmettin Erbakan Universitesi /ID# 239848Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Upadacitinib

Arm 2: Placebo for Upadacitinib

Arm Description

Participants will be administered updadacitinib once daily (QD) along with prednisolone.

Participants will be administered placebo once daily (QD) along with prednisolone.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
November 12, 2019
Last Updated
October 4, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04161898
Brief Title
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
August 30, 2027 (Anticipated)
Study Completion Date
August 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu Arteritis (TAK)
Keywords
Takayasu Arteritis (TAK), Upadacitinib, Placebo, Corticosteroid, Prednisolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Upadacitinib
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib once daily (QD) along with prednisolone.
Arm Title
Arm 2: Placebo for Upadacitinib
Arm Type
Experimental
Arm Description
Participants will be administered placebo once daily (QD) along with prednisolone.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Upadacitinib will be administered as oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for Upadacitinib
Intervention Description
Placebo for upadacitinib will be administered as oral tablet
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone will be administered as oral tablet
Primary Outcome Measure Information:
Title
Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period
Description
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.
Time Frame
Up to occurrence of 40 events (approximately 52 months)
Secondary Outcome Measure Information:
Title
Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period
Description
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.
Time Frame
Up to occurrence of 40 events (approximately 52 months)
Title
Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period
Description
Imaging with computed tomography angiogram (CTA).
Time Frame
Up to occurrence of 40 events (approximately 52 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Italiano La Plata /ID# 249269
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1902
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Guemes /ID# 249675
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1180
Country
Argentina
Individual Site Status
Recruiting
Facility Name
SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150-150
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
LMK Sevicos Medicos S/S /ID# 240645
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital do Rim /ID# 240380
City
Sao Paulo
ZIP/Postal Code
04038-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 241175
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital /ID# 248350
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen People's Hospital /ID# 248347
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University /ID# 248107
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Xuanwu Hospital Capital Medical University /ID# 248104
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital Fudan University /ID# 247159
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Chiba University Hospital /ID# 214932
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ehime University Hospital /ID# 215424
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Maebashi Red Cross Hospital /ID# 230513
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0811
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 215066
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital /ID# 215318
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagawa University Hospital /ID# 214776
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Marianna University Hospital /ID# 214535
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Hospital /ID# 214345
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital /ID# 215128
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital /ID# 214066
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyagi Children's Hospital /ID# 248390
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
989-3126
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagano Red Cross Hospital /ID# 214537
City
Nagano-shi
State/Province
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital /ID# 215683
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital /ID# 214499
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Osaka Minami Medical Center /ID# 228779
City
Kawachinagano Shi
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital /ID# 216491
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cerebral and Cardiovascular Center /ID# 214061
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital /ID# 214292
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical And Dental University Hospital /ID# 214138
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
St.Luke's International Hospital /ID# 214067
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital /ID# 214905
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Center Hospital of the National Center for Global Health and Medicine /ID# 214931
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Women's Medical University Hospital /ID# 215129
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yonsei University Health System Severance Hospital /ID# 215643
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hanyang University Seoul Hospital /ID# 213842
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 213844
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital /ID# 229543
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214566
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hacettepe University Faculty of Medicine /ID# 239845
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Univ Medical Faculty /ID# 240015
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz University Faculty /ID# 239847
City
Antalya
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846
City
Istanbul
ZIP/Postal Code
34480
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty /ID# 240139
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Necmettin Erbakan Universitesi /ID# 239848
City
Meram Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M19-052
Description
Related Info

Learn more about this trial

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

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