Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396756
Other study ID # PLN-74809-IPF-202
Secondary ID INTEGRIS-IPF
Status Completed
Phase Phase 2
First received
Last updated
Start date March 3, 2020
Est. completion date February 15, 2023

Study information

Verified date February 2024
Source Pliant Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 15, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

Drug:
PLN-74809
PLN-74809
Placebo
Placebo

Locations

Country Name City State
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia The Alfred Hospital Melbourne Victoria
Belgium UZ Leuven Leuven
Canada CISSS de la Montérégie Centre Greenfield Park Quebec
Canada Dr. Anil Dhar Medicine Professional Corporation Windsor Ontario
Italy San Giuseppe Hospital, Multimedica S.p.a. Milan
Netherlands Catharina Ziekenhuis Eindhoven EJ
Netherlands Canisius-Wilhelmina Ziekenhuis Nijmegen SZ
New Zealand University of Otago Christchurch Christchurch
New Zealand New Zealand Respiratory and Sleep Institute Greenlane Auckland
United States The Emory Clinic Atlanta Georgia
United States Brigham and Women's Hospital Boston Massachusetts
United States Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield Chesterfield Missouri
United States PulmonIx Greensboro North Carolina
United States Baylor College of Medicine Houston Texas
United States Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine Los Angeles California
United States Vanderbilt Lung Institute at One Hundred Oaks Nashville Tennessee
United States Yale University Scool of Medicine/ Yale New Haven Hospital New Haven Connecticut
United States Pulmonary Associates, PA Phoenix Arizona
United States UPMC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Pliant Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Italy,  Netherlands,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Other Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12. Up to 12 weeks
Other Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC) Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24. Up to 24 weeks
Other Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12 Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic. Up to 12 weeks
Other Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24 Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic. Up to 24 weeks
Other Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity. Up to 12 weeks
Other Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity. Up to 24 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Part A - Assessment of PLN-74809 Total Plasma Concentrations Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose Week 4, 1 Hour Post Dose
Secondary Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose Week 12, 2 Hours Post Dose
Secondary Part D - Assessment of PLN-74809 Total Plasma Concentrations Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose Week 24, 2 Hours Post Dose
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05984992 - The First-in-human Study of SRN-001 in Healthy Participants Phase 1
Active, not recruiting NCT04312594 - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT03865927 - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979430 - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study N/A
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Not yet recruiting NCT06241560 - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood Phase 2
Terminated NCT04419558 - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 3
Completed NCT03725852 - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Terminated NCT03573505 - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT04148157 - Quality of Life in IPF - Patient and Physician Perceptions
Completed NCT03222648 - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis N/A
Not yet recruiting NCT06422884 - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) Phase 2
Completed NCT02268981 - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF) N/A
Completed NCT02257177 - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients Phase 1/Phase 2
Withdrawn NCT01524068 - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 2
Enrolling by invitation NCT01382368 - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients Phase 4
Completed NCT01199887 - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis Phase 1
Completed NCT01110694 - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting NCT02951416 - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3