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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Research Site
Liverpool, New South Wales, Australia
Research Site
Benowa, Queensland, Australia
Change from baseline in frequency of adverse events (AEs)
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.
Time frame: Baseline to Week 18
Change from baseline in severity of AEs
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.
Time frame: Baseline to Week 18
Change from baseline in vital sign measurements - pulse
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.
Time frame: Baseline to Week 18
Change from baseline in vital sign measurements - blood pressure
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.
Time frame: Baseline to Week 18
Change from baseline in vital sign measurements - respiration rate
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.
Time frame: Baseline to Week 18
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Research Site
Box Hill, Victoria, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Vancouver, British Columbia, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Batu Caves, Malaysia
Research Site
Kota Bharu, Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Sire
Kuala Lumpur, Malaysia
...and 14 more locations
Change from baseline in vital sign measurements - temperature
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.
Time frame: Baseline to Week 18
Change from baseline in blood oxygen saturation level
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.
Time frame: Baseline to Week 18
Incidence of clinical laboratory abnormalities
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.
Time frame: Baseline to Week 18
Severity of clinical laboratory abnormalities
Assessment of the severity (defined as either clinically significant or not clinically significant) for the clinical laboratory abnormalities observed during the study.
Time frame: Baseline to Week 18
Number of hospitalizations
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.
Time frame: Baseline to Week 18
Change from baseline of FVC (forced vital capacity)
FVC is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured during a spirometry test.
Time frame: Baseline and Week 12
Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)
DLCO is a measurement of the ease of transfer for carbon monoxide molecules from alveolar gas to the hemoglobin of the red blood cells in the pulmonary circulation.
Time frame: Baseline and Week 12
Change from baseline of patient reported outcomes by the University of California-San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
The UCSD SOBQ consists of 24 questions (21 assess severity of shortness of breath during specific activities of daily living; 3 additional items ask about limitations due to: shortness of breath, fear of harm from overexertion and fear of shortness of breath). Each question has a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness"), resulting in a total score ranging from 0 to 120 (a higher score represents a worse outcome).
Time frame: Baseline and Week 12