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Taladegib for Pulmonary Fibrosis

Phase 2

Waitlist Available

Research Sponsored by Endeavor Biomedicines, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 18

Awards & highlights

Study Summary

This trial is testing a new drug for IPF, a disease that causes lung tissue to become scarred and makes it hard to breathe. The trial will last 18 weeks.

Eligible Conditions

Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in blood oxygen saturation level

Change from baseline in frequency of adverse events (AEs)

Change from baseline in severity of AEs

+7 more

Secondary outcome measures

Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)

Change from baseline of FVC (forced vital capacity)

Change from baseline of patient reported outcomes by the University of California-San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)

Other outcome measures

Change from baseline of DLCO

Change from baseline of FVC

Change from baseline of patient reported outcomes by the UCSD SOBQ

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ENV-101Experimental Treatment1 Intervention

taladegib, 200 mg tablet, once daily for 12 weeks

Group II: placeboPlacebo Group1 Intervention

placebo, tablet, once daily for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

taladegib

2021

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Endeavor Biomedicines, Inc.Lead Sponsor

2 Previous Clinical Trials

65 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

21 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Paul Frohna, M.D., Ph.D.Study DirectorEndeavor Biomedicines

2 Previous Clinical Trials

65 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

21 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Srikanth Pendyala, M.D.Study DirectorEndeavor Biomedicines

2 Previous Clinical Trials

65 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

21 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

placebo Clinical Trial Eligibility Overview. Trial Name: NCT04968574 — Phase 2

Idiopathic Pulmonary Fibrosis Research Study Groups: ENV-101, placebo

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: placebo Highlights & Side Effects. Trial Name: NCT04968574 — Phase 2

placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968574 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has taladegib received clearance from the FDA?

"Taladegib's safety has been partially tested and is thus awarded a score of 2 on our 1 to 3 risk assessment scale. As this is only a Phase 2 trial, there are no results published that demonstrate its efficacy."

Answered by AI

Are there vacancies that can be filled by participants in this clinical investigation?

"Affirmative, the trial is open for enrolment. Records on clinicaltrials.gov reveal that it was originally posted in August of 2021 and underwent its latest revision in December 2022. The research needs to enlist 60 patients from two different hospitals."

Answered by AI

What is the participant number for this experiment?

"Affirmative. Details shared on clinicaltrials.gov reveal that the medical study, inaugurated on August 26th 2021, is still seeking volunteers. The team seeks to enrol 60 individuals across 2 sites for this trial."

Answered by AI

Does this trial break new ground in the medical field?

"Taladegib has been studied since 2021, with the initial trial being conducted by Endeavor Biomedicines, Inc.. This experiment involved 60 patients and ultimately resulted in taladegib entering Phase 2 of drug approval. Currently there is one active study for this medication sponsored by Endeavor Biomedicines, Inc.."

Answered by AI

What precedent has been set for the use of taladegib in clinical trials?

"At present, there exists one live clinical trial for taladegib and none are in the third phase. Locations that offer this medication range from San Nicolás De Los Garza, Nuevo Leon to a further twenty other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968574.