Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

Study Purpose

A Phase 2a, multicenter, 3-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B & C) - FVC %predicted ≥45% - DLco (hemoglobin-adjusted) ≥30% - Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months.

Exclusion Criteria:

  • - Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA.
  • - Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7 at Screening.
  • - Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression.
  • - Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening.
- Smoking of any kind within 3 months of Screening

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04396756
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pliant Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pliant Therapeutics Medical Monitor
Principal Investigator Affiliation Pliant Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

Three part study: Part A

  • - 4 week treatment period evaluating PLN-74809 or matching placebo.
Part B
  • - 12 week treatment period evaluating PLN-74809 or matching placebo.
Part C - 12 week treatment period evaluating up to two higher PLN-74809 dose cohorts or matching placebo

Arms & Interventions

Arms

Experimental: Placebo

Placebo

Experimental: PLN-74809 Dose Level 1 (Part A)

PLN-74809 Dose Level 1 (Part A) - 4 weeks

Experimental: PLN-74809 Dose Level 2 (Part A)

PLN-74809 Dose Level 2 (Part A) - 4 weeks

Experimental: PLN-74809 Dose Level 2 (Part B)

PLN-74809 Dose Level 2 (Part B) - 12 weeks

Experimental: PLN-74809 - Dose Level 3 (Part C)

PLN-74809 Dose Level 3 (Part C) - 12 weeks

Experimental: PLN-74809 - Dose Level 4 (Part C)

PLN-74809 Dose Level 4 (Part C) - 12 weeks

Interventions

Drug: - PLN-74809

PLN-74809

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pulmonary Associates, Phoenix, Arizona

Status

Recruiting

Address

Pulmonary Associates

Phoenix, Arizona, 85032

SBPA Research LLC, Santa Barbara, California

Status

Recruiting

Address

SBPA Research LLC

Santa Barbara, California, 93105

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Central Florida Pulmonary Group, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group

Orlando, Florida, 32803

Emory Clinic, Atlanta, Georgia

Status

Recruiting

Address

Emory Clinic

Atlanta, Georgia, 30322

Austell, Georgia

Status

Recruiting

Address

Piedmont Healthcare Pulmonary and Critical Care Research

Austell, Georgia, 30106

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

St. Luke's Hospital, Chesterfield, Missouri

Status

Recruiting

Address

St. Luke's Hospital

Chesterfield, Missouri, 63017

Pulmonary and Allergy Associates, Summit, New Jersey

Status

Recruiting

Address

Pulmonary and Allergy Associates

Summit, New Jersey, 07901

Pulmonix, Greensboro, North Carolina

Status

Recruiting

Address

Pulmonix

Greensboro, North Carolina, 27403

Oklahoma City, Oklahoma

Status

Recruiting

Address

Integris Nazih Zuhdi Transplant Institute

Oklahoma City, Oklahoma, 73112

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84112

International Sites

Toronto, Ontario, Canada

Status

Recruiting

Address

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4

Windsor, Ontario, Canada

Status

Recruiting

Address

Dr. Anil Dhar Medicine Professional Corporation

Windsor, Ontario, N8W1L9

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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