A Phase 2a Randomized, Doubled-Blind, Placebo-Controlled Trial to Evaluate Safety, Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.
详细描述
This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1
- •≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause.
- •Participants must have a moderate exacerbation of COPD according to the Rome guidelines
- •≥ 10 pack-years smoking history.
排除标准
- •Endotracheal intubation or mechanical ventilation.
- •Participants with severe exacerbation of COPD according to the Rome guidelines
- •Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status
- •Interstitial lung disease.
- •Current or prior history of asthma.
- •Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)
- •Preexisting autoimmune disease: History of autoimmune disease and/or use of chronic steroids of >10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment
- •Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.
- •Has confounding medical conditions, including:
- •diabetic coma,
- •uncontrolled New York Heart Association Class IV congestive heart failure,
- •uncontrolled angina,
- •stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
- •clinically significant arrhythmias not controlled by medication, or
- •idiopathic pulmonary fibrosis,
- •Has a weight >120 kg at Screening.
- •Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
- •Has systemic immunosuppression/immune deficiency
研究组 & 干预措施
RLS-0071
Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days
干预措施: RLS-0071 (Drug)
Placebo
Doses of Placebo for RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 to Day 60
次要结局
- Time to reach maximum observed serum concentration (Tmax) for RLS-0071(Day 1 and Day 3)
- Mortality rate of participants at 60 days after discharge(Day 1 to Day 60)
- Measure respiratory rate by measuring breaths per minute daily(Day 1 - Up to Day 5)
- Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071(Day 1 and Day 3)
- Terminal Phase Elimination Half-Life (t1/2) for RLS-0071(Day 1 and Day 3)
- Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.(Day 0 up to Day 5.)
- Number of participants rehospitalized for COPD up to Day 60(Day 1 to Day 60)
- Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.(Day 0 up to Day 5.)
- Measure the % O2 saturation via pulse oximetry daily(Day 1 - Up to Day 5)
- Maximum Observed Serum Concentration (Cmax) for RLS-0071(Day 1 and Day 3)
- Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.(Day 0 up to Day 5.)
- Number of participants that progressed to mechanical ventilation(Day 1 - Day 5)
- Measure heart rate via beats per minute daily(Day 1 - Up to Day 5)
- Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.(Day 0 up to Day 5.)
- Number of days participant was hospitalized (length of stay).(Day 1 - Day 60)