A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis

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Updated on 23 November 2020
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Summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis

 

Description

Oral Drug Period 1: 52 Weeks. To evaluate the efficacy of upadacitinib 7.5 mg once daily (QD) and 15 mg QD in combination with a 26-week CS taper regimen compared to PBO in combination with a 52-week CS taper regimen, as measured by the proportion of subjects in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in subjects with GCA. Period 2: 52 Weeks. To evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in subjects who achieved remission in Period 1.

Details
Condition Arthritis and Arthritic Pain
Clinical Study IdentifierTX219142
Last Modified on23 November 2020

Eligibility

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Inclusion Criteria

Diagnosis of GCA according to the following criteria
Adult male or female, ≥50 years of age
History of ESR ≥ 50 mm/hour or CRP ≥ 2.45 mg/dL
Presence of at least one of the following
Unequivocal cranial symptoms of GCA, or Unequivocal symptoms of PMR shoulder and/or hip girdle pain associated with inflammatory morning stiffness)
Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, MRI, CT or PET
Active new onset or relapsing GCA with active disease within 6 weeks of Baseline
Subjects must have initiated treatment with ≥ 40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) ≥ 20 mg QD at Baseline
Subjects must have GCA that, in the opinion of the investigator, is clinically stable to allow the subject to safely initiate the protocol-defined CS taper regimen

Exclusion Criteria

No previous exposure to JAK inhibitor
No hx of cerebrovascular accident, MI, coronary stinting <6 Mo
History of any malignancy except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix
Subject must not have any clinically significant medical condition or other reason which, in the opinion of the investigator, would make the subject an unsuitable candidate to receive study drug or would put the subject at risk by participating in the study
Subject has not been treated with any investigational drug of chemical or biologic nature (see Section 5.3 for additional information on biologic therapies) within a minimum of 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or is not currently enrolled in another interventional clinical study
Subject must not have chronic use of systemic CS for > 3 years or an inability, in the opinion of the investigator, to withdraw from CS treatment through the protocol-defined taper regimen
Subject must not have had > 2 courses of systemic CS therapy to treat conditions other than GCA within 1 year prior to baseline
Subject must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class, or to corticosteroids
Subject must not have received oral Traditional Chinese Medicines within 4 weeks prior to Baseline or use of marijuana (medical or recreational) within 2 weeks prior to Baseline
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