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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 : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

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

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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




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 ]


Information from the National Library of Medicine

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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
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

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
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Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com

Locations
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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
Sponsors and Collaborators
Pliant Therapeutics, Inc.
Investigators
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Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial