Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: PLN-74809 Drug: Placebo Phase 2

Detailed Description:

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : March 31, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 12 weeks ]

Other Outcome Measures:
  1. Part A - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 28 days ]
  2. Part B & C - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 12 weeks ]
  3. Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12 [ Time Frame: Up to 12 weeks ]
  4. Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Pliant Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: August 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases