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

Phase 3

Active, not recruiting

• Conditions: Takayasu Arteritis (TAK)
• Interventions: Drug: Upadacitinib; Drug: Placebo for Upadacitinib; Drug: Prednisolone

• Registration Number: NCT04161898
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Study Start: 2020-02-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Placebo for Upadacitinib	Placebo for Upadacitinib	Participants will be administered placebo once daily (QD) along with prednisolone.
Arm 2: Placebo for Upadacitinib	Prednisolone	Participants will be administered placebo once daily (QD) along with prednisolone.
Arm 1: Upadacitinib	Upadacitinib	Participants will be administered updadacitinib once daily (QD) along with prednisolone.
Arm 1: Upadacitinib	Prednisolone	Participants will be administered updadacitinib once daily (QD) along with prednisolone.
Arm 2: Placebo for Upadacitinib	Upadacitinib	Participants will be administered placebo once daily (QD) along with prednisolone.

Primary Outcome Measures

Name	Time	Method
Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period	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 OR where the criteria are met based on one category per protocol definition of relapse of TAK.

Secondary Outcome Measures

Name	Time	Method
Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period	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.
Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period	Up to occurrence of 40 events (approximately 52 months)	Imaging with computed tomography angiogram (CTA).

Trial Locations

Locations (48)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175; 🇧🇷 Sao Paulo, Brazil

Institute of Science Tokyo Hospital /ID# 214138; 🇯🇵 Bunkyo-ku, Tokyo, Japan

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Hospital Italiano La Plata /ID# 249269; 🇦🇷 La Plata, Buenos Aires, Argentina

Sanatorio Guemes /ID# 249675; 🇦🇷 Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina

SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125; 🇧🇷 Salvador, Bahia, Brazil

CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil

CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502; 🇧🇷 Curitiba, Parana, Brazil

LMK Sevicos Medicos S/S /ID# 240645; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital do Rim /ID# 240380; 🇧🇷 Sao Paulo, Brazil

Guangdong Provincial People's Hospital /ID# 248350; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen People's Hospital /ID# 248347; 🇨🇳 Shenzhen, Guangdong, China

Xuanwu Hospital Capital Medical University /ID# 248104; 🇨🇳 Beijing, Guizhou, China

The First Hospital of China Medical University /ID# 248107; 🇨🇳 Shenyang, Liaoning, China

Zhongshan Hospital Fudan University /ID# 247159; 🇨🇳 Shanghai, Shanghai, China

Chiba University Hospital /ID# 214932; 🇯🇵 Chiba-shi, Chiba, Japan

Ehime University Hospital /ID# 215424; 🇯🇵 Toon-shi, Ehime, Japan

Maebashi Red Cross Hospital /ID# 230513; 🇯🇵 Maebashi-shi, Gunma, Japan

Hokkaido University Hospital /ID# 215066; 🇯🇵 Sapporo-shi, Hokkaido, Japan

University of Tsukuba Hospital /ID# 215318; 🇯🇵 Tsukuba-shi, Ibaraki, Japan

Kagawa University Hospital /ID# 214776; 🇯🇵 Kita-gun, Kagawa, Japan

St. Marianna University Hospital /ID# 214535; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

Yokohama City University Hospital /ID# 214345; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Kyoto University Hospital /ID# 215128; 🇯🇵 Kyoto-shi, Kyoto, Japan

Tohoku University Hospital /ID# 214066; 🇯🇵 Sendai-shi, Miyagi, Japan

Miyagi Children's Hospital /ID# 248390; 🇯🇵 Sendai-shi, Miyagi, 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

National Hospital Organization Osaka Minami Medical Center /ID# 228779; 🇯🇵 Kawachinagano Shi, Osaka, Japan

Kindai University Hospital /ID# 216491; 🇯🇵 Osakasayama-shi, Osaka, Japan

National Cerebral and Cardiovascular Center /ID# 214061; 🇯🇵 Suita-shi, Osaka, Japan

Juntendo University Hospital /ID# 214292; 🇯🇵 Bunkyo-ku, Tokyo, Japan

St.Luke's International Hospital /ID# 214067; 🇯🇵 Chuo-ku, Tokyo, Japan

Keio University Hospital /ID# 214905; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Center hospital of the National Center for Global Health and Medicine /ID# 214931; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital /ID# 215129; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Seoul National University Hospital /ID# 213844; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Hanyang University Seoul Hospital /ID# 213842; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Gangnam Severance Hospital /ID# 229543; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Yonsei University Health System Severance Hospital /ID# 215643; 🇰🇷 Seoul, Korea, Republic of

Akdeniz University Faculty /ID# 239847; 🇹🇷 Antalya, Adana, Turkey

Ege University Medical Faculty /ID# 240139; 🇹🇷 Izmir, Adana, Turkey

Hacettepe University Faculty of Medicine /ID# 239845; 🇹🇷 Ankara, Turkey

Ankara Univ Medical Faculty /ID# 240015; 🇹🇷 Ankara, Turkey

Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846; 🇹🇷 Istanbul, Turkey

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844; 🇹🇷 Istanbul, Turkey

Necmettin Erbakan Universitesi /ID# 239848; 🇹🇷 Meram Konya, Turkey