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PLN-74809 for Idiopathic Pulmonary Fibrosis

Phase 2
Waitlist Available
Research Sponsored by Pliant Therapeutics, 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 up to 48 weeks
Awards & highlights

Study Summary

This trial is testing a new drug to treat idiopathic pulmonary fibrosis. The drug will be given once daily and the study will evaluate the safety, tolerability, and pharmacokinetics of the drug.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
Part B & C - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
Part D - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
Secondary outcome measures
Part A, B & C - Assessment of PLN-74809 plasma concentrations
Part D - Assessment of PLN-74809 plasma concentrations
Other outcome measures
Part A - Assessment of change from baseline in forced vital capacity (FVC)
Part B & C - Assessment of change from baseline in a visual analog scale (VAS) scale for cough
Part B & C - Assessment of change from baseline in forced vital capacity (FVC)
+4 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo
Group II: PLN-74809 Dose Level 2 (Part B)Experimental Treatment1 Intervention
PLN-74809 Dose Level 2 (Part B) - 12 weeks
Group III: PLN-74809 Dose Level 2 (Part A)Experimental Treatment1 Intervention
PLN-74809 Dose Level 2 (Part A) - 4 weeks
Group IV: PLN-74809 Dose Level 1 (Part A)Experimental Treatment1 Intervention
PLN-74809 Dose Level 1 (Part A) - 4 weeks
Group V: PLN-74809 - Dose Level 5 (Part D)Experimental Treatment1 Intervention
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
Group VI: PLN-74809 - Dose Level 4 (Part C)Experimental Treatment1 Intervention
PLN-74809 Dose Level 4 (Part C) - 12 weeks
Group VII: PLN-74809 - Dose Level 3 (Part C)Experimental Treatment1 Intervention
PLN-74809 Dose Level 3 (Part C) - 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PLN-74809
2020
Completed Phase 2
~260
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Pliant Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
613 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
409 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Pliant Therapeutics Medical MonitorStudy DirectorPliant Therapeutics, Inc.
4 Previous Clinical Trials
567 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
369 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Frequently Asked Questions

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

Is recruitment still open for this medical research?

"Unfortunately, this medical experiment is not seeking participants at the current time. Originally posted on 3rd of March 2020 and last edited on 17th August 2022, it has been placed in a state of hiatus. However, there are 410 other trials presently recruiting patients for their studies."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to PLN-74809?

"There are preliminary data that suggest PLN-74809 is safe, thus receiving a score of 2. However, there is presently no evidence demonstrating efficacy for this drug."

Answered by AI

How widely dispersed is the management of this scientific research?

"27 medical centres are recruiting patients for this trial, including Pulmonary and Allergy Associates in Summit, CISSS de la Montérégie-Centre in Greenfield Park, Dr. Anil K. Gupta Medicine Professional Corporation in Toronto, as well as 24 other locations."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Cedars Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Have tried Rituximab for: IPF- hypersensitive pneumonitis - and have seen my PFT tests decline. Hoped Ritux would have kept lung function steady. So am looking for alternative treatments.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
2020. "Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04396756.
~24 spots leftby Apr 2025
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