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

• ClinicalTrials.gov Identifier: NCT04161898
• Recruitment Status: Recruiting
• First Posted: November 13, 2019
• Last Update Posted: August 9, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: November 12, 2019
• First Posted Date: November 13, 2019
• Last Update Posted Date: August 9, 2022
• Actual Study Start Date: February 4, 2020
• Estimated Primary Completion Date: April 23, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 9, 2022)

Time to First Relapse of Takayasu Arteritis (TAK) From Baseline [ Time Frame: 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.

Original Primary Outcome Measures (submitted: November 12, 2019)

Time to First Relapse of Takayasu Arteritis (TAK) From Baseline [ Time Frame: Up to occurrence of 40 events (approximately 31 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.

Current Secondary Outcome Measures (submitted: June 9, 2022)

• Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline [ Time Frame: 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 [ Time Frame: Up to occurrence of 40 events (approximately 52 months) ]
  Imaging with computed tomography angiogram (CTA).

Original Secondary Outcome Measures (submitted: November 12, 2019)

• Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline [ Time Frame: Up to occurrence of 40 events (approximately 31 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 [ Time Frame: Up to occurrence of 40 events (approximately 31 months) ]
  Imaging with computed tomography angiogram (CTA).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (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)
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Takayasu Arteritis (TAK)

Intervention

• 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

Study Arms

• Experimental: Arm 1: Upadacitinib
  Participants will be administered updadacitinib once daily (QD) along with prednisolone.
  Interventions:

  • Drug: Upadacitinib
  • Drug: Prednisolone
• Experimental: Arm 2: Placebo for Upadacitinib
  Participants will be administered placebo once daily (QD) along with prednisolone.
  Interventions:

  • Drug: Upadacitinib
  • Drug: Placebo for Upadacitinib
  • Drug: Prednisolone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 12, 2019): 56
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2027
• Estimated Primary Completion Date: April 23, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: Brazil, China, Japan, Korea, Republic of, Turkey

Administrative Information

• NCT Number: NCT04161898
• Other Study ID Numbers: M19-052
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: August 2022