Status and phase
Conditions
Treatments
About
The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in this patient population.
Full description
This trial is a 6-month, randomized, double-blind, controlled, dose-ranging trial of ENV-101 in adult patients with idiopathic pulmonary fibrosis (IPF). Patients are allowed to continue treatment with approved standard of care (e.g., nintedanib, pirfenidone) during the trial. Patients will be randomized to one of 3 dose levels of ENV-101 or placebo at baseline. The objectives of this trial are to characterize the efficacy, antifibrotic activity, and safety of ENV-101 to select the Phase 3 dose of ENV-101.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Evidence of other known causes of interstitial lung disease (ILD).
Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at study start.
History of malignancy, including carcinoma during the preceding 5 years from study start, with the following exceptions:
Patients with moderate to severe hepatic impairment (Child-Pugh B and C).
Smoking (including vaping) within 6 months of study start; current smoker, or unwillingness to refrain from smoking during the clinical trial duration.
Active or suspected alcohol or drug abuse in the opinion of the Investigator.
Currently enrolled in another investigational device or drug trial, or less than 3 months from study start since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to study start or planned during the course of the trial. Being on a transplant list is allowed.
Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
Current or previous use (within 28 days prior to study start) of the following:
Use of cyclophosphamide or tocilizumab within 8 weeks, or rituximab within 6 months, prior to study start.
Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 14 days prior to study start. Patients must also agree not to eat fruits that inhibit CYP3A4 such as grapefruit, Seville oranges, pomelo and star fruit.
Patients 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 of study drug.
Females that are pregnant or nursing.
Patients that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of study drug.
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 dose of study drug.
Patients with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101.
Patients who have previously taken ENV-101.
Primary purpose
Allocation
Interventional model
Masking
200 participants in 4 patient groups, including a placebo group
Loading...
Central trial contact
Endeavor Clinical Trials
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal