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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
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 Idiopathic Pulmonary Fibrosis

Eligibility Criteria

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

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

Sites / Locations

  • Pulmonary Associates, PA
  • Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
  • Yale University Scool of Medicine/ Yale New Haven Hospital
  • The Emory Clinic
  • Brigham and Women's Hospital
  • Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield
  • PulmonIx
  • UPMC
  • Vanderbilt Lung Institute at One Hundred Oaks
  • Baylor College of Medicine
  • Royal Prince Alfred Hospital
  • The Alfred Hospital
  • UZ Leuven
  • Dr. Anil Dhar Medicine Professional Corporation
  • CISSS de la Montérégie Centre
  • San Giuseppe Hospital, Multimedica S.p.a.
  • Catharina Ziekenhuis
  • Canisius-Wilhelmina Ziekenhuis
  • New Zealand Respiratory and Sleep Institute
  • University of Otago Christchurch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

PLN-74809 Dose Level 1 (Part A)

PLN-74809 Dose Level 2 (Part A)

PLN-74809 Dose Level 2 (Part B)

PLN-74809 - Dose Level 3 (Part C)

PLN-74809 - Dose Level 4 (Part C)

PLN-74809 - Dose Level 5 (Part D)

Arm Description

Placebo

PLN-74809 Dose Level 1 (Part A) - 4 weeks

PLN-74809 Dose Level 2 (Part A) - 4 weeks

PLN-74809 Dose Level 2 (Part B) - 12 weeks

PLN-74809 Dose Level 3 (Part C) - 12 weeks

PLN-74809 Dose Level 4 (Part C) - 12 weeks

PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks

Outcomes

Primary Outcome Measures

Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
Part B & C - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
Part D - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0

Secondary Outcome Measures

Part A, B & C - Assessment of PLN-74809 plasma concentrations
Part D - Assessment of PLN-74809 plasma concentrations

Full Information

First Posted
May 6, 2020
Last Updated
June 21, 2023
Sponsor
Pliant Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04396756
Brief Title
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 15, 2023 (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
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo
Arm Title
PLN-74809 Dose Level 1 (Part A)
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 1 (Part A) - 4 weeks
Arm Title
PLN-74809 Dose Level 2 (Part A)
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 2 (Part A) - 4 weeks
Arm Title
PLN-74809 Dose Level 2 (Part B)
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 2 (Part B) - 12 weeks
Arm Title
PLN-74809 - Dose Level 3 (Part C)
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 3 (Part C) - 12 weeks
Arm Title
PLN-74809 - Dose Level 4 (Part C)
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 4 (Part C) - 12 weeks
Arm Title
PLN-74809 - Dose Level 5 (Part D)
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
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
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
Title
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
Title
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 Measure Information:
Title
Part A, B & C - Assessment of PLN-74809 plasma concentrations
Time Frame
Up to 12 weeks
Title
Part D - Assessment of PLN-74809 plasma concentrations
Time Frame
Up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Part A - Assessment of change from baseline in forced vital capacity (FVC)
Time Frame
Up to 28 days
Title
Part B & C - Assessment of change from baseline in forced vital capacity (FVC)
Time Frame
Up to 12 weeks
Title
Part D - Assessment of change from baseline in forced vital capacity (FVC)
Time Frame
Up to 48 weeks
Title
Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12
Time Frame
Up to 12 weeks
Title
Part D - Change in pulmonary fibrosis score by quantitative HRCT at Week 24
Time Frame
Up to 24 weeks
Title
Part B & C - Assessment of change from baseline in a visual analog scale (VAS) scale for cough
Time Frame
Up to 12 weeks
Title
Part D - Assessment of change from baseline in a visual analog scale (VAS) scale for cough
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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 % of 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pliant Therapeutics Medical Monitor
Organizational Affiliation
Pliant Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Yale University Scool of Medicine/ Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017-3625
Country
United States
Facility Name
PulmonIx
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Lung Institute at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Dr. Anil Dhar Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
CISSS de la Montérégie Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
San Giuseppe Hospital, Multimedica S.p.a.
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
EJ
ZIP/Postal Code
5623
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
SZ
ZIP/Postal Code
6532
Country
Netherlands
Facility Name
New Zealand Respiratory and Sleep Institute
City
Greenlane
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
University of Otago Christchurch
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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