Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04396756 |
Recruitment Status :
Recruiting
First Posted : May 21, 2020
Last Update Posted : November 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: PLN-74809 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF) |
Actual Study Start Date : | March 3, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | January 31, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Placebo
Placebo
|
Drug: Placebo
Placebo |
Experimental: PLN-74809 Dose Level 1 (Part A)
PLN-74809 Dose Level 1 (Part A) - 4 weeks
|
Drug: PLN-74809
PLN-74809 |
Experimental: PLN-74809 Dose Level 2 (Part A)
PLN-74809 Dose Level 2 (Part A) - 4 weeks
|
Drug: PLN-74809
PLN-74809 |
Experimental: PLN-74809 Dose Level 2 (Part B)
PLN-74809 Dose Level 2 (Part B) - 12 weeks
|
Drug: PLN-74809
PLN-74809 |
Experimental: PLN-74809 - Dose Level 3 (Part C)
PLN-74809 Dose Level 3 (Part C) - 12 weeks
|
Drug: PLN-74809
PLN-74809 |
Experimental: PLN-74809 - Dose Level 4 (Part C)
PLN-74809 Dose Level 4 (Part C) - 12 weeks
|
Drug: PLN-74809
PLN-74809 |
- Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 28 days ]
- Part B & C - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 12 weeks ]
- Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 12 weeks ]
- Part A - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 28 days ]
- Part B & C - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 12 weeks ]
- Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12 [ Time Frame: Up to 12 weeks ]
- Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 12 weeks ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396756
Contact: Pliant Therapeutics Medical Monitor | clintrials@pliantrx.com | clintrials@pliantrx.com |
United States, Arizona | |
Pulmonary Associates | Recruiting |
Phoenix, Arizona, United States, 85032 | |
United States, California | |
SBPA Research LLC | Recruiting |
Santa Barbara, California, United States, 93105 | |
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 | |
United States, Florida | |
Central Florida Pulmonary Group | Recruiting |
Orlando, Florida, United States, 32803 | |
United States, Georgia | |
Emory Clinic | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Piedmont Healthcare Pulmonary and Critical Care Research | Recruiting |
Austell, Georgia, United States, 30106 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, Missouri | |
St. Luke's Hospital | Recruiting |
Chesterfield, Missouri, United States, 63017 | |
United States, New Jersey | |
Pulmonary and Allergy Associates | Recruiting |
Summit, New Jersey, United States, 07901 | |
United States, North Carolina | |
Pulmonix | Recruiting |
Greensboro, North Carolina, United States, 27403 | |
United States, Oklahoma | |
Integris Nazih Zuhdi Transplant Institute | Recruiting |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
United States, Utah | |
University of Utah | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Canada, Ontario | |
Dr. Anil K. Gupta Medicine Professional Corporation | Recruiting |
Toronto, Ontario, Canada, M9V 4B4 | |
Dr. Anil Dhar Medicine Professional Corporation | Recruiting |
Windsor, Ontario, Canada, N8W1L9 |
Study Director: | Pliant Therapeutics Medical Monitor | Pliant Therapeutics, Inc. |
Responsible Party: | Pliant Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04396756 |
Other Study ID Numbers: |
PLN-74809-IPF-202 INTEGRIS-IPF ( Other Identifier: Pliant Therapeutics ) |
First Posted: | May 21, 2020 Key Record Dates |
Last Update Posted: | November 18, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |