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

NCT04161898 · tracked via the Priya Life Science Turkey tracker

Sponsor

AbbVie

Phase

Phase 3

Started

2020-02-04

Last updated

2026-02-18

Condition(s) studied

Takayasu Arteritis (TAK)

Investigational drug(s) / intervention(s)

Upadacitinib →Placebo for UpadacitinibPrednisolone →

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

Study 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.

Eligibility

Sex

ALL

Min age

15 Years

Max age

—

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.

Primary outcome measure(s)

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.
Number of Participants with Adverse Events (AEs) — Up to approximately 58 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (48)

Facility	City	Region
Fundación Sanatorio Guemes /ID# 249675	Ciudad Autonoma Buenos Aires	Buenos Aires
Hospital Italiano La Plata /ID# 249269	La Plata	Buenos Aires
SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125	Salvador	Estado de Bahia
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517	Juiz de Fora	Minas Gerais
CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502	Curitiba	Paraná
LMK Sevicos Medicos S/S /ID# 240645	Porto Alegre	Rio Grande do Sul
Hospital do Rim /ID# 240380	São Paulo	Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175	São Paulo	Brazil
Xuanwu Hospital Capital Medical University /ID# 248104	Beijing	Beijing Municipality
Guangdong Provincial Peoples Hospital /ID# 248350	Guangzhou	Guangdong
Shenzhen People's Hospital /ID# 248347	Shenzhen	Guangdong
First Affiliated Hospital of China Medical University /ID# 248107	Shenyang	Liaoning
Zhongshan Hospital Fudan University /ID# 247159	Shanghai	Shanghai Municipality
Chiba University Hospital /ID# 214932	Chiba	Chiba
Ehime University Hospital /ID# 215424	Toon-shi	Ehime
Maebashi Red Cross Hospital /ID# 230513	Maebashi	Gunma
Duplicate_Hokkaido University Hospital /ID# 215066	Sapporo	Hokkaido
University of Tsukuba Hospital /ID# 215318	Tsukuba	Ibaraki
Kagawa University Hospital /ID# 214776	Kita-gun	Kagawa-ken
St Marianna University School Of Medicine /ID# 214535	Kawasaki-shi	Kanagawa
Yokohama City University Hospital /ID# 214345	Yokohama	Kanagawa
Duplicate_Kyoto University Hospital /ID# 215128	Kyoto	Kyoto
Tohoku University Hospital /ID# 214066	Sendai	Miyagi
Miyagi Children's Hospital /ID# 248390	Sendai	Miyagi
Nagano Red Cross Hospital /ID# 214537	Nagano	Nagano
Duplicate_Nagasaki University Hospital /ID# 215683	Nagasaki	Nagasaki
Okayama University Hospital /ID# 214499	Okayama	Okayama-ken
National Hospital Organization Osaka Minami Medical Center /ID# 228779	Kawachinagano Shi	Osaka
Kindai University Hospital /ID# 216491	Sakai-shi	Osaka
National Cerebral and Cardiovascular Center /ID# 214061	Suita-shi	Osaka
Juntendo University Hospital /ID# 214292	Bunkyo-ku	Tokyo
Institute of Science Tokyo Hospital /ID# 214138	Bunkyo-ku	Tokyo
St. Lukes International Hospital /ID# 214067	Chuo-ku	Tokyo
Duplicate_Keio University Hospital /ID# 214905	Shinjuku-ku	Tokyo
National Center for Global Health and Medicine /ID# 214931	Shinjuku-ku	Tokyo
Duplicate_Tokyo Women's Medical University Hospital /ID# 215129	Shinjuku-ku	Tokyo
Seoul National University Hospital /ID# 213844	Seoul	Seoul Teugbyeolsi
Hanyang University Seoul Hospital /ID# 213842	Seoul	Seoul Teugbyeolsi
Gangnam Severance Hospital /ID# 229543	Seoul	Seoul Teugbyeolsi
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566	Seoul	Seoul Teugbyeolsi

+ 8 more sites — see the full list on the official registry below.

On this site

📄 Rinvoq (upadacitinib) drug profile →

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04161898 on ClinicalTrials.gov ↗ ← All trials in Turkey