A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Change from baseline in vital sign measurements - blood pressure
研究概览
简要总结
This is a Phase 2, randomized, placebo controlled, multi-center study in subjects with mild to moderate IPF. Eligible subjects will be randomized to receive placebo or ENV-101 as a daily oral dose for 12 consecutive weeks of treatment. Following treatment, subjects will be observed for an additional 6 weeks.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF diagnosis based upon American Thoracic Association, Japanese Respiratory Society, European Respiratory Society, Latin American Thoracic Association guidelines within the last 7 years. Diagnosis will be confirmed to be consistent with IPF by centrally read high resolution computed tomography (HRCT).
- •Ability to successfully perform lung function tests.
- •Subjects are willing to remain on study treatment for the duration of the study.
- •Subjects have a full understanding of the informed consent.
排除标准
- •Evidence of other known causes of interstitial lung disease (ILD) (e.g., domestic, and occupational environmental exposures, connective tissue disease [CTD], and drug toxicity), lung transplant expected within 12 months of screening or evidence of clinically significant lung disease other than IPF including but not limited to asthma, chronic obstructive pulmonary disease (COPD), uncontrolled pulmonary hypertension and emphysema where computed tomography (CT)-assessed extent of emphysema is greater than extent of fibrosis.
- •History of malignancy, including carcinoma during the preceding 5 years. With the following exceptions:
- •Prior history of in situ basal or squamous cell skin cancer that was successfully treated with curative therapies.
- •Subjects with other malignancies if they have been continuously disease free for at least 5 years prior to study start.
- •Subjects with prostate cancer that are managed by surveillance are also eligible.
- •Current use of supplemental oxygen for any condition unless prior approval is received from the Sponsor.
- •Smoking within 6 months of study start, current smoker, or unwillingness to refrain from smoking during the clinical trial duration.
- •Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- •Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
- •Current or previous use (within 30 days prior to study start) of the following:
- •N-acetylcysteine
- •endothelin receptor antagonist
- •prostacyclin or prostacyclin analogue
- •Warfarin for IPF
- •Cytotoxic agents (e.g., colchicine if used for IPF)
- •Radiation to the lungs
- •Pulmonary rehabilitation
- •Investigational agent for IPF
- •Immunosuppressive medications (e.g., methotrexate, azathioprine)
- •Systemic or inhaled glucocorticosteroids
- •Antifibrotic therapy (e.g., nintedanib, pirfenidone)
- •Regular use of phosphodiesterase type-5 inhibitor, occasional use for erectile dysfunction will be allowed.
- •Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 12 days prior to study start.
- •Males and females of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose.
- •Females that are pregnant or nursing.
- •Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose.
- •Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final study dose.
- •Subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-
- •Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor.
研究组 & 干预措施
ENV-101
taladegib, 200 mg tablet, once daily for 12 weeks
干预措施: taladegib (Drug)
placebo
placebo, tablet, once daily for 12 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in vital sign measurements - blood pressure
时间窗: Baseline to Week 18
Comparison of a subject's blood pressure at the beginning of the study to that subject's blood pressure at the completion of the study.
Change from baseline in vital sign measurements - respiration rate
时间窗: Baseline to Week 18
Comparison of a subject's respiration rate (number of breaths taken per minute while at rest) at the beginning of the study to that subject's respiration rate at the completion of the study.
Change from baseline in blood oxygen saturation level
时间窗: Baseline to Week 18
Comparison of a subject's blood oxygen saturation level (measured at rest using a pulse oximeter) at the beginning of the study to that subject's blood oxygen saturation level at the completion of the study.
Number of hospitalizations
时间窗: Baseline to Week 18
Assessment of the number of hospitalizations for any reason observed among all subjects from the beginning of the study to the completion of the study.
Change from baseline in severity of AEs
时间窗: Baseline to Week 18
Severity of AEs are categorized as mild, moderate or severe as described below: * Mild - Events require minimal or no treatment and do not interfere with the subject's daily activities. * Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. * Severe - Events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.
Change from baseline in frequency of adverse events (AEs)
时间窗: Baseline to Week 18
An AE is any untoward medical occurrence in a study subject administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment under investigation. Frequency of a given AE is determined by dividing the total number of that AE observed during the study by the total number of subjects in the study.
Change from baseline in vital sign measurements - temperature
时间窗: Baseline to Week 18
Comparison of a subject's body temperature at the beginning of the study to that subject's body temperature at the completion of the study.
Severity of clinical laboratory abnormalities
时间窗: Baseline to Week 18
Assessment of the severity (defined as either clinically significant or not clinically significant) for the clinical laboratory abnormalities observed during the study.
Change from baseline in vital sign measurements - pulse
时间窗: Baseline to Week 18
Comparison of a subject's pulse rate at the beginning of the study to that subject's pulse rate at the completion of the study.
Incidence of clinical laboratory abnormalities
时间窗: Baseline to Week 18
Assessment of the clinical laboratory measurements (chemistry, hematology, urinalysis parameters) that are above or below the laboratory normal ranges. Incidence of clinical laboratory abnormalities is determined by dividing the total number of clinical laboratory abnormalities by the total number of subjects in the study.
次要结局
- Change from baseline of FVC (forced vital capacity)(Baseline and Week 12)
- Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)(Baseline and Week 12)
- Change from baseline of patient reported outcomes by the University of California-San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)(Baseline and Week 12)