EUCTR2021-000648-23-IT进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluatethe Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment - A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of ABBV-154
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adults 50 – 80 years of age with a clinical diagnosis of PMR and fulfillment of the 2012 EULAR/ACR provisional classification criteria for PMR.
- •2. Following a confirmed diagnosis of PMR, subject must have shown a clinical response to prednisone (or equivalent dose) of 5 to 25 mg/day.
- •3. Subject must have had at least 2 episodes of unequivocal PMR flare while attempting to taper prednisone, with the dose of prednisone (or equivalent) at the time of flare = 5 mg/day, prior to Baseline; the most recent flare must have been within 24 weeks of Baseline. Unequivocal PMR flare is defined as clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of
- •motion of hips and/or shoulders) that resulted in an increase in glucocorticoid dose.
- •4. Subject must be on a stable prednisone (or equivalent) dose of 5 to 15 mg/day for = 2 weeks prior to Baseline. Subjects may be on up to 25 mg/day at the Screening Visit provided that the subject is able to taper to 15 mg/day or less, with a stable dose = 2 weeks prior to Baseline.
- •5. Subject must be willing to follow the protocol-defined glucocorticoid tapering regimen.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Subject must have discontinued use of immunomodulators other than prednisone (or equivalent) prior to Baseline
- •2. Subjects requiring > 25 mg/day of prednisone to control confirmed PMR are excluded
- •3. Subject must not exhibit clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders) within 2 weeks of Baseline
研究者
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