Bnai Zion Medical Center | Neurology Clinic
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About
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.
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Inclusion criteria
Diagnosis of giant cell arteritis (GCA) according to the following criteria:
Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
Participants must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily (QD) at Baseline.
Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen.
Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.
Exclusion criteria
Prior exposure to any Janus Kinase (JAK) inhibitor.
Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:
Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
Female who is pregnant, breastfeeding, or considering pregnancy during the study.
Primary purpose
Allocation
Interventional model
Masking
429 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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