A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK) (SELECT-TAK)
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| ClinicalTrials.gov Identifier: NCT04161898 |
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Recruitment Status :
Recruiting
First Posted : November 13, 2019
Last Update Posted : June 13, 2022
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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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 |
|---|---|---|
| Takayasu Arteritis (TAK) | Drug: Upadacitinib Drug: Placebo for Upadacitinib Drug: Prednisolone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 : | February 4, 2020 |
| Estimated Primary Completion Date : | April 23, 2024 |
| Estimated Study Completion Date : | August 30, 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1: Upadacitinib
Participants will be administered updadacitinib once daily (QD) along with prednisolone.
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Drug: Upadacitinib
Upadacitinib will be administered as oral tablet
Other Names:
Drug: Prednisolone Prednisolone will be administered as oral tablet |
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Experimental: Arm 2: Placebo for Upadacitinib
Participants will be administered placebo once daily (QD) along with prednisolone.
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Drug: Upadacitinib
Upadacitinib will be administered as oral tablet
Other Names:
Drug: Placebo for Upadacitinib Placebo for upadacitinib will be administered as oral tablet Drug: Prednisolone Prednisolone will be administered as oral tablet |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161898
Contacts
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
Locations
Show 40 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT04161898 |
| Other Study ID Numbers: |
M19-052 |
| First Posted: | November 13, 2019 Key Record Dates |
| Last Update Posted: | June 13, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (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 Statistical Analysis Plan (SAP) 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/ |
| 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:
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Takayasu Arteritis (TAK) Upadacitinib Placebo Corticosteroid Prednisolone |
Additional relevant MeSH terms:
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Arteritis Takayasu Arteritis Aortic Arch Syndromes Vasculitis Vascular Diseases Cardiovascular Diseases Aortic Diseases Skin Diseases, Vascular Skin Diseases Prednisolone Upadacitinib Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |