Trials / Completed
CompletedNCT04968574
A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Endeavor Biomedicines, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | taladegib | hedgehog pathway inhibitor dosed once daily |
| DRUG | placebo | identical tablets to the experimental arm with no active ingredient |
Timeline
- Start date
- 2021-08-26
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2021-07-20
- Last updated
- 2024-12-02
Locations
24 sites across 5 countries: Australia, Canada, Malaysia, Mexico, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04968574. Inclusion in this directory is not an endorsement.