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Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

Primary Purpose

Acute Respiratory Distress Syndrome, SARS-CoV-2

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PLN-74809
Placebo
Sponsored by
Pliant Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of ARDS (Berlin Criteria)
  • Hospitalized with at least severe COVID-19 (FDA 2020)
  • Receiving support for acute lung injury/respiratory distress via supplemental oxygen
  • Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine aminotransferase (ALT) concentration ≤ 150 U/L
  • Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis

Exclusion Criteria:

  • Greater than 72 hours since time of onset of ARDS.
  • Greater than 7 days since start of mechanical ventilation.
  • Currently receiving or anticipated to receive extracorporeal life support (ECLS), extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation
  • Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6 mL/kg of predicted body weight and prone positioning) and fluid management protocol (Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local institutional standards (HFOV).

Sites / Locations

  • Valleywise Health Medical Center
  • Cedars-Sinai Medical Center
  • National Jewish Health
  • Advent Health
  • Augusta University Medical Center
  • Atlantic Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PLN-74809 Dose Level1

PLN-74809 Dose Level 2

PLN74809 Dose Level 3

Arm Description

Dose Level 1 of PLN-74809

Dose Level 2 of PLN-74809

Dose Level 3 of PLN-74809

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2020
Last Updated
October 27, 2022
Sponsor
Pliant Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04565249
Brief Title
Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19
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 Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19 (INTEGRIS-ARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Study halted and will not resume; participants are no longer being examined or receiving intervention
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pliant Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
Detailed Description
Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio). In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLN-74809 Dose Level1
Arm Type
Experimental
Arm Description
Dose Level 1 of PLN-74809
Arm Title
PLN-74809 Dose Level 2
Arm Type
Experimental
Arm Description
Dose Level 2 of PLN-74809
Arm Title
PLN74809 Dose Level 3
Arm Type
Experimental
Arm Description
Dose Level 3 of PLN-74809
Intervention Type
Drug
Intervention Name(s)
PLN-74809
Intervention Description
PLN-74809
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
Description
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.
Time Frame
Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ARDS (Berlin Criteria) Hospitalized with at least severe COVID-19 (FDA 2020) Receiving support for acute lung injury/respiratory distress via supplemental oxygen Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine aminotransferase (ALT) concentration ≤ 150 U/L Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis Exclusion Criteria: Greater than 72 hours since time of onset of ARDS. Greater than 7 days since start of mechanical ventilation. Currently receiving or anticipated to receive extracorporeal life support (ECLS), extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6 mL/kg of predicted body weight and prone positioning) and fluid management protocol (Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local institutional standards (HFOV).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pliant Therapeutics
Organizational Affiliation
Pliant Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Valleywise Health Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Atlantic Health System
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

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