NCT05415137已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 93
- 主要终点
- Change from baseline in mean daily oral corticosteroid (OCS) dose at Week 48
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence
- •Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
- •Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day
- •Body weight ≥ 40 kg and < 160 kg
排除标准
- •Treatment with > 1 immunosuppressant therapy
- •Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors
- •Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis > 20% within the last 12 months; FVC percent predicted (FVCPP) < 50% and KSQ-Lung score < 30
- •In the opinion of the investigator, clinically significant pulmonary hypertension
- •Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years
- •Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy
- •History of Addisonian symptoms that precluded previous OCS taper attempts
- •Is an active, heavy smoker of tobacco/nicotine-containing products
- •History of anti-synthetase syndrome or Jo-1 positive at Screening
- •Patients with active tuberculosis or those currently undergoing treatment for tuberculosis
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Efzofitimod 5 mg/kg
Experimental
干预措施: Efzofitimod 5 mg/kg (Drug)
Efzofitimod 3 mg/kg
Experimental
干预措施: Efzofitimod 3 mg/kg (Drug)
结局指标
主要结局
Change from baseline in mean daily oral corticosteroid (OCS) dose at Week 48
时间窗: Baseline to Week 48
次要结局
- Change from baseline in KSQ-Lung score at Week 48(Baseline to Week 48)
- Steroid withdrawal rate(Baseline to Week 48)
- Change from baseline in absolute value of FVC at Week 48(Baseline to Week 48)
研究者
研究点 (93)
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