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

Idiopathic Pulmonary Fibrosis Clinical Trial

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)

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
• 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
• 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

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