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

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Takayasu Arteritis (TAK)

Treatments: Drug: Placebo for Upadacitinib; Drug: Prednisolone; Drug: Upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04161898

M19-052

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Arm 1: Upadacitinib

Experimental group

Description:

Participants will be administered updadacitinib once daily (QD) along with prednisolone.

Treatment:

Drug: Upadacitinib

Drug: Prednisolone

Arm 2: Placebo for Upadacitinib

Experimental group

Description:

Participants will be administered placebo once daily (QD) along with prednisolone.

Treatment:

Drug: Upadacitinib

Drug: Prednisolone

Drug: Placebo for Upadacitinib