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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396756
Recruitment Status : Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Study Description
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Brief Summary:
A Phase 2a, multicenter, 4-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:

Four 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 intermediatery PLN-74809 doses or matching placebo

Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 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 : February 28, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Experimental: PLN-74809 - Dose Level 5 (Part D)
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
 Drug: PLN-74809
PLN-74809


Outcome Measures
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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 ]
  3. Part D - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 48 weeks ]

Secondary Outcome Measures :
  1. Part A, B & C - Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 12 weeks ]
  2. Part D - Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 24 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 D - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 48 weeks ]
  4. Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12 [ Time Frame: Up to 12 weeks ]
  5. Part D - Change in pulmonary fibrosis score by quantitative HRCT at Week 24 [ Time Frame: Up to 24 weeks ]
  6. Part B & C - Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 12 weeks ]
  7. Part D - Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 48 weeks ]

Eligibility Criteria
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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 & D)
  • 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
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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


Locations
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Sponsors and Collaborators
Pliant Therapeutics, Inc.
Investigators
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Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
More Information
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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: August 18, 2022
Last Verified: April 2022
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