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)
Verified date | February 2024 |
Source | Pliant Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Pliant Therapeutics, Inc. |
United States, Australia, Belgium, Canada, Italy, Netherlands, New Zealand,
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 |
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