A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Browse trials for

• Pulmonary Fibrosis 680
• Idiopathic Pulmonary Fibrosis 551
• Fibrosis 3,255

Keywords

• hedgehog
• smoothened
• pulmonary fibrosis

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 41 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Lead sponsor

Endeavor Biomedicines, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  ENV-101

  taladegib, 200 mg tablet, once daily for 12 weeks

  Drug: taladegib

• Placebo comparator
  placebo

  placebo, tablet, once daily for 12 weeks

  Drug: placebo

Interventions

• Drugtaladegib

  hedgehog pathway inhibitor dosed once daily

• Drugplacebo

  identical tablets to the experimental arm with no active ingredient

Primary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

Secondary outcomes

1. 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

2. 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

3. 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

Other outcomes

1. Change from baseline of FVC

   Time frame: Baseline and Week 6

2. Change from baseline of FVC

   Time frame: Baseline and Week 18

3. Change from baseline of DLCO

   Time frame: Baseline and Week 6

4. Change from baseline of DLCO

   Time frame: Baseline and Week 18

5. Change from baseline of patient reported outcomes by the UCSD SOBQ

   Time frame: Baseline and Week 6

6. Change from baseline of patient reported outcomes by the UCSD SOBQ

   Time frame: Baseline and Week 18

Individual participant data

Plan to share: No