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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Takayasu Arteritis (TAK)
• Intervention / Treatment: Drug: Upadacitinib; Drug: Prednisolone; Drug: Placebo for Upadacitinib

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Argentina
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1902
      • Hospital Italiano La Plata /ID# 249269
  • Ciudad Autonoma De Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1180
      • Sanatorio Guemes /ID# 249675
• Brazil
  • Sao Paulo, Brazil, 04038-002
    • Hospital do Rim /ID# 240380
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 241175
  • Bahia
    • Salvador, Bahia, Brazil, 40150-150
      • SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517
  • Parana
    • Curitiba, Parana, Brazil, 80030-110
      • CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
      • LMK Sevicos Medicos S/S /ID# 240645
• China
  • Beijing, China, 100053
    • Xuanwu Hospital Capital Medical University /ID# 248104
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University /ID# 247159
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital /ID# 248350
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen People's Hospital /ID# 248347
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University /ID# 248107
• Japan
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8677
      • Chiba University Hospital /ID# 214932
  • Ehime
    • Toon-shi, Ehime, Japan, 791-0295
      • Ehime University Hospital /ID# 215424
  • Gunma
    • Maebashi-shi, Gunma, Japan, 371-0811
      • Maebashi Red Cross Hospital /ID# 230513
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 215066
  • Ibaraki
    • Tsukuba-shi, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital /ID# 215318
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Kagawa University Hospital /ID# 214776
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital /ID# 214535
    • Yokohama-shi, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital /ID# 214345
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 215128
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 214066
    • Sendai-shi, Miyagi, Japan, 989-3126
      • Miyagi Children's Hospital /ID# 248390
  • Nagano
    • Nagano-shi, Nagano, Japan, 380-8582
      • Nagano Red Cross Hospital /ID# 214537
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital /ID# 215683
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 214499
  • Osaka
    • Kawachinagano Shi, Osaka, Japan, 586-8521
      • National Hospital Organization Osaka Minami Medical Center /ID# 228779
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 216491
    • Suita-shi, Osaka, Japan, 564-8565
      • National Cerebral and Cardiovascular Center /ID# 214061
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 214292
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical And Dental University Hospital /ID# 214138
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital /ID# 214067
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 214905
    • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Center hospital of the National Center for Global Health and Medicine /ID# 214931
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital /ID# 215129
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 213844
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital /ID# 229543
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214566
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Yonsei University Health System Severance Hospital /ID# 215643
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
      • Hanyang University Seoul Hospital /ID# 213842
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Faculty of Medicine /ID# 239845
  • Ankara, Turkey, 06590
    • Ankara Univ Medical Faculty /ID# 240015
  • Antalya, Turkey, 06100
    • Akdeniz University Faculty /ID# 239847
  • Istanbul, Turkey, 34480
    • Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846
  • Istanbul, Turkey, 34899
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 240139
  • Meram Konya, Turkey, 42080
    • Necmettin Erbakan Universitesi /ID# 239848

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Upadacitinib; Participants will be administered updadacitinib once daily (QD) along with prednisolone.	Drug: Upadacitinib; Upadacitinib will be administered as oral tablet; Other Names: RINVOQ; ABT-494; Drug: Prednisolone; Prednisolone will be administered as oral tablet
Experimental: Arm 2: Placebo for Upadacitinib; Participants will be administered placebo once daily (QD) along with prednisolone.	Drug: Upadacitinib; Upadacitinib will be administered as oral tablet; Other Names: RINVOQ; ABT-494; Drug: Prednisolone; Prednisolone will be administered as oral tablet; Drug: Placebo for Upadacitinib; Placebo for upadacitinib will be administered as oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Upadacitinib; Corticosteroid; Prednisolone; Placebo; Takayasu Arteritis (TAK)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Prednisolone; Upadacitinib
• Other Study ID Numbers: M19-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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