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

NCT04396756 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: PLN-74809-IPF-202INTEGRIS-IPF
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 20

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (6)

• Part A - Number of Participants With Treatment-Emergent Adverse Events

  An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.

  Up to 4 weeks

• Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events

  An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.

  Up to 12 weeks

• Part D - Number of Participants With Treatment-Emergent Adverse Events

  An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.

  Up to 48 weeks

• Part A - Number of Participants With Serious Treatment-Emergent Adverse Events

  An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.

  Up to 4 weeks

• Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events

  An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.

  Up to 12 weeks

• Part D - Number of Participants With Serious Treatment-Emergent Adverse Events

  An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.

  Up to 48 weeks

Secondary Outcomes (3)

• Part A - Assessment of PLN-74809 Total Plasma Concentrations

  Week 4, 1 Hour Post Dose

• Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations

  Week 12, 2 Hours Post Dose

• Part D - Assessment of PLN-74809 Total Plasma Concentrations

  Week 24, 2 Hours Post Dose

Other Outcomes (6)

• Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)

  Up to 12 weeks

• Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)

  Up to 24 weeks

• Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12

  Up to 12 weeks

Study Arms (7)

Placebo

EXPERIMENTAL

Placebo

Drug: Placebo

PLN-74809 Dose Level 1 (Part A)

EXPERIMENTAL

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

Drug: PLN-74809

PLN-74809 Dose Level 2 (Part A)

EXPERIMENTAL

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

Drug: PLN-74809

PLN-74809 Dose Level 2 (Part B)

EXPERIMENTAL

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

Drug: PLN-74809

PLN-74809 - Dose Level 3 (Part C)

EXPERIMENTAL

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

Drug: PLN-74809

PLN-74809 - Dose Level 4 (Part C)

EXPERIMENTAL

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

Drug: PLN-74809

PLN-74809 - Dose Level 5 (Part D)

EXPERIMENTAL

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

Drug: PLN-74809

Interventions

PLN-74809 DRUG

PLN-74809

PLN-74809 - Dose Level 3 (Part C); PLN-74809 - Dose Level 4 (Part C); PLN-74809 - Dose Level 5 (Part D); PLN-74809 Dose Level 1 (Part A); PLN-74809 Dose Level 2 (Part A); PLN-74809 Dose Level 2 (Part B)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pliant Therapeutics, Inc.: lead

Study Sites (20)

Pulmonary Associates, PA

Phoenix, Arizona, 85032, United States

Location

Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine

Los Angeles, California, 90048, United States

Location

Yale University Scool of Medicine/ Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield

Chesterfield, Missouri, 63017-3625, United States

Location

PulmonIx

Greensboro, North Carolina, 27403, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Lung Institute at One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Dr. Anil Dhar Medicine Professional Corporation

Windsor, Ontario, N8X 5A6, Canada

Location

CISSS de la Montérégie Centre

Greenfield Park, Quebec, J4V 2H1, Canada

Location

San Giuseppe Hospital, Multimedica S.p.a.

Milan, 20123, Italy

Location

Catharina Ziekenhuis

Eindhoven, EJ, 5623, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, SZ, 6532, Netherlands

Location

New Zealand Respiratory and Sleep Institute

Greenlane, Auckland, 1051, New Zealand

Location

University of Otago Christchurch

Christchurch, 8011, New Zealand

Location

Related Publications (1)

• Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC.

  PMID: 38843105 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gregory P. Cosgrove, MD, Vice President, Clinical Development
• Organization: Pliant Therapeutics, Inc.

GCosgrove@pliantrx.com

1-650-481-6770

Study Officials

• Pliant Therapeutics Medical Monitor

  Pliant Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 21, 2020
• Study Start: March 3, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 15, 2023
• Last Updated: June 3, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); NZ (2); BE (1); NL (2); CA (2); AU (2); US (10)