NCT04533022已完成2 期
A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 21
- 主要终点
- Number of Participants With Adverse Events Occurring Over the Trial Period
研究概览
简要总结
This trial is a multi-centre, open-label, single-arm phase 2 trial investigating the safety, efficacy and pharmacokinetics of C21 in subjects with idiopathic pulmonary fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
- •A diagnosis of IPF within 5 years prior to Visit 1, as per either ATS/ERS/JRS/ATLAT/Fleischner guidelines
- •Age ≥40 years
- •Forced vital capacity (FVC) ≥60% predicted at Visit 1 (specifically for UK: FVC ≥80% predicted at Visit 1)
- •Forced expiratory volume in the first sec (FEV1)/FVC ratio ≥0.7 prebronchodilator at Visit 1
- •Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1
- •High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating either a or b, and c:
- •a. A pattern consistent with usual interstitial pneumonitis (UIP) according to ATS/ERS/JRS/ALAT or Fleischner guidelines i. UIP ii. Probable UIP or b. A pattern indeterminate for UIP according to either ATS/ERS/JRS/ALAT or Fleischner guidelines and a historical biopsy consistent with IPF c. Extent of fibrosis > extent of emphysema
- •Fully vaccinated against COVID-19 prior to screening (Visit 1). Subjects are considered fully vaccinated for COVID-19 ≥14 days after they have received vaccination dose(s) according to local label
排除标准
- •Previous use of antifibrotic treatment for an interstitial lung disease (e.g. nintedanib or pirfenidone) for > 6 months
- •Smoking (including e-cigarettes) within 6 months prior to Visit 1
- •Body mass index (BMI) >35 or <18
- •IPF exacerbation within 3 months prior to Visit 1:
- •Acute worsening or development of dyspnoea typically <1 month duration
- •Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier "new" can be dropped)
- •Deterioration not fully explained by cardiac failure or fluid overload
- •Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery) which in the opinion of the investigator makes the subject inappropriate for this trial
- •Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
- •Treatment with any of the medications listed below within 4 weeks prior to Visit 1:
- •Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort)
- •CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
- •Medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
- •Experimental drugs
- •Any systemic immunosuppressive therapies other than:
- •Inhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable
- •Corticosteroids for the treatment of acute exacerbations
- •The continuation of stable doses of ≤15 mg daily doses of prednisolone
- •Treatment with any of the medications listed below within 2 weeks prior to Visit 1:
- •Proton pump inhibitors (PPI's) more than once daily
- •Histamine H2 receptor antagonists (H2RA's)
- •Sulphasalazine and rosuvastatin
- •High dose breast cancer resistance protein sensitive substrates (other than sulphasalazine or rosuvastatin)
- •Any of the following findings at Visit 1:
- •Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
- •Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab)
- •Positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin)
- •Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline, as determined by central review
- •Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator
- •Pregnant or breast-feeding female subjects
- •Female subjects of childbearing potential not willing to use contraceptive methods
- •Male subjects not willing to use contraceptive methods
- •Subjects not willing to adhere to dietary restrictions during the trial period
- •Participation in any other interventional trial during the trial period
- •Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- •Discontinuation or change of previous antifibrotic treatment (e.g. nintedanib or pirfenidone) due to disease progression
研究组 & 干预措施
C21
Experimental
C21 100 mg BID (twice daily)
干预措施: C21 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events Occurring Over the Trial Period
时间窗: Trial period of 36 weeks
Number of participants with adverse events occurring over the trial period incl. number of participants with any TEAE, serious TEAEs, TEAEs leading to withdrawal from trial, TEAEs leading to discontinuation of treatment, treatment-related TEAEs leading to discontinuation of treatment, TEAEs leading to death, and serious treatment-related TEAEs. Adverse events were recorded from signing of informed consent until end of trial. Nature and frequency of adverse events are presented in details in the adverse events section.
次要结局
- AUClast in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
- Accumulation Ratio AUC in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
- Tmax in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
- Change From Baseline in Forced Vital Capacity (Non-imputed Data)(12, 24, and 36 weeks)
- Change From Baseline in Forced Vital Capacity (Imputed Data)(12, 24, and 36 weeks)
- Rate of Forced Vital Capacity Decline Over Time, FAS(12, 24, and 36 weeks)
- Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose on Day 1)
- Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 12)
- Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 24)
- Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 36)
- Cmax in a Sub-set of Subjects(Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36)
研究者
研究点 (21)
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