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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04161898
Collaborator
(none)
56
Enrollment
45
Locations
2
Arms
90.8
Anticipated Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 4, 2020
Anticipated Primary Completion Date :
Apr 23, 2024
Anticipated Study Completion Date :
Aug 30, 2027

Arms and Interventions

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:
  • ABT-494
  • RINVOQ

    • 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:
  • ABT-494
  • RINVOQ

    • Drug: Placebo for Upadacitinib
    Placebo for upadacitinib will be administered as oral tablet

    Drug: Prednisolone
    Prednisolone will be administered as oral tablet

    Outcome Measures

    Primary Outcome Measures

    1. Time to First Relapse of Takayasu Arteritis (TAK) From Baseline [Up to occurrence of 40 events (approximately 52 months)]

      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.

    Secondary Outcome Measures

    1. Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline [Up to occurrence of 40 events (approximately 52 months)]

      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.

    2. Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline [Up to occurrence of 40 events (approximately 52 months)]

      Imaging with computed tomography angiogram (CTA).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SER - Servicos Especializados em Reumatologia /ID# 243125 Salvador Bahia Brazil 40150-150
    2 CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517 Juiz de Fora Minas Gerais Brazil 36010-570
    3 CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502 Curitiba Parana Brazil 80030-110
    4 LMK Sevicos Medicos S/S /ID# 240645 Porto Alegre Rio Grande Do Sul Brazil 90480-000
    5 Hospital do Rim /ID# 240380 Sao Paulo Brazil 04038-002
    6 Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 241175 Sao Paulo Brazil 05403-000
    7 Guangdong Provincial People's Hospital /ID# 248350 Guangzhou Guangdong China 510080
    8 The First Hospital of China Medical University /ID# 248107 Shenyang Liaoning China 110001
    9 Xuanwu Hospital Capital Medical University /ID# 248104 Beijing China 100053
    10 Zhongshan Hospital Fudan University /ID# 247159 Shanghai China 200032
    11 Chiba University Hospital /ID# 214932 Chiba-shi Chiba Japan 260-8677
    12 Ehime University Hospital /ID# 215424 Toon-shi Ehime Japan 791-0295
    13 Maebashi Red Cross Hospital /ID# 230513 Maebashi-shi Gunma Japan 371-0811
    14 Hokkaido University Hospital /ID# 215066 Sapporo-shi Hokkaido Japan 060-8648
    15 University of Tsukuba Hospital /ID# 215318 Tsukuba-shi Ibaraki Japan 305-8576
    16 Kagawa University Hospital /ID# 214776 Kita-gun Kagawa Japan 761-0793
    17 St. Marianna University Hospital /ID# 214535 Kawasaki-shi Kanagawa Japan 216-8511
    18 Yokohama City University Hospital /ID# 214345 Yokohama-shi Kanagawa Japan 236-0004
    19 Kyoto University Hospital /ID# 215128 Kyoto-shi Kyoto Japan 606-8507
    20 Tohoku University Hospital /ID# 214066 Sendai-shi Miyagi Japan 9808574
    21 Miyagi Children's Hospital /ID# 248390 Sendai-shi Miyagi Japan 989-3126
    22 Nagano Red Cross Hospital /ID# 214537 Nagano-shi Nagano Japan 380-8582
    23 Nagasaki University Hospital /ID# 215683 Nagasaki-shi Nagasaki Japan 852-8501
    24 Okayama University Hospital /ID# 214499 Okayama-shi Okayama Japan 700-8558
    25 National Hospital Organization Osaka Minami Medical Center /ID# 228779 Kawachinagano Shi Osaka Japan 586-8521
    26 Kindai University Hospital /ID# 216491 Osakasayama-shi Osaka Japan 589-8511
    27 National Cerebral and Cardiovascular Center /ID# 214061 Suita-shi Osaka Japan 564-8565
    28 Juntendo University Hospital /ID# 214292 Bunkyo-ku Tokyo Japan 113-8431
    29 Tokyo Medical And Dental University Hospital /ID# 214138 Bunkyo-ku Tokyo Japan 113-8519
    30 St.Luke's International Hospital /ID# 214067 Chuo-ku Tokyo Japan 104-8560
    31 Keio University Hospital /ID# 214905 Shinjuku-ku Tokyo Japan 160-8582
    32 Center Hospital of the National Center for Global Health and Medicine /ID# 214931 Shinjuku-ku Tokyo Japan 162-8655
    33 Tokyo Women's Medical University Hospital /ID# 215129 Shinjuku-ku Tokyo Japan 162-8666
    34 Yonsei University Health System Severance Hospital /ID# 215643 Seoul Seoul Teugbyeolsi Korea, Republic of 03722
    35 Hanyang University Seoul Hospital /ID# 213842 Seoul Seoul Teugbyeolsi Korea, Republic of 04763
    36 Seoul National University Hospital /ID# 213844 Seoul Korea, Republic of 03080
    37 Gangnam Severance Hospital /ID# 229543 Seoul Korea, Republic of 06273
    38 The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214566 Seoul Korea, Republic of 06591
    39 Hacettepe University Faculty of Medicine /ID# 239845 Ankara Turkey 06100
    40 Ankara Univ Medical Faculty /ID# 240015 Ankara Turkey 06590
    41 Akdeniz University Faculty /ID# 239847 Antalya Turkey 06100
    42 Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844 Istanbul Turkey 34899
    43 Ege University Medical Faculty /ID# 240139 Izmir Turkey 35040
    44 Necmettin Erbakan Universitesi /ID# 239848 Meram Konya Turkey 42080
    45 Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846 Tuzla Turkey 34953

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04161898
    Other Study ID Numbers:
    • M19-052
    First Posted:
    Nov 13, 2019
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Takayasu Arteritis (TAK)
    Upadacitinib
    Placebo
    Corticosteroid
    Prednisolone
    Additional relevant MeSH terms:
    Arteritis
    Takayasu Arteritis
    Aortic Arch Syndromes
    Prednisolone
    Upadacitinib

    Study Results

    No Results Posted as of Aug 24, 2022