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

NCT04968574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-12-02

No results posted yet for this study

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

DRUG

taladegib

hedgehog pathway inhibitor dosed once daily

DRUG

placebo

identical tablets to the experimental arm with no active ingredient

Sponsors & Collaborators

  • Endeavor Biomedicines, Inc.

    lead INDUSTRY

Principal Investigators

  • John Huetsch, M.D. · Endeavor Biomedicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • Malaysia
  • Mexico
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04968574 on ClinicalTrials.gov