Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT04396756
- Lead Sponsor
- Pliant Therapeutics, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo PLN-74809 Dose Level 1 (Part A) PLN-74809 PLN-74809 Dose Level 1 (Part A) - 4 weeks PLN-74809 Dose Level 2 (Part A) PLN-74809 PLN-74809 Dose Level 2 (Part A) - 4 weeks PLN-74809 Dose Level 2 (Part B) PLN-74809 PLN-74809 Dose Level 2 (Part B) - 12 weeks PLN-74809 - Dose Level 3 (Part C) PLN-74809 PLN-74809 Dose Level 3 (Part C) - 12 weeks PLN-74809 - Dose Level 4 (Part C) PLN-74809 PLN-74809 Dose Level 4 (Part C) - 12 weeks PLN-74809 - Dose Level 5 (Part D) PLN-74809 PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
- Primary Outcome Measures
Name Time Method Part A - Number of Participants With Serious Treatment-Emergent Adverse Events Up to 4 weeks 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.
Part A - Number of Participants With Treatment-Emergent Adverse Events Up to 4 weeks 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.
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events Up to 12 weeks 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.
Part D - Number of Participants With Treatment-Emergent Adverse Events Up to 48 weeks 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.
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events Up to 12 weeks 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.
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events Up to 48 weeks 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.
- Secondary Outcome Measures
Name Time Method Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose
Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose 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 B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose
Trial Locations
- Locations (20)
UZ Leuven
🇧🇪Leuven, Belgium
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
CISSS de la Montérégie Centre
🇨🇦Greenfield Park, Quebec, Canada
San Giuseppe Hospital, Multimedica S.p.a.
🇮🇹Milan, Italy
Dr. Anil Dhar Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Catharina Ziekenhuis
🇳🇱Eindhoven, EJ, Netherlands
Canisius-Wilhelmina Ziekenhuis
🇳🇱Nijmegen, SZ, Netherlands
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Yale University Scool of Medicine/ Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield
🇺🇸Chesterfield, Missouri, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
New Zealand Respiratory and Sleep Institute
🇳🇿Greenlane, Auckland, New Zealand
University of Otago Christchurch
🇳🇿Christchurch, New Zealand
Vanderbilt Lung Institute at One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
PulmonIx
🇺🇸Greensboro, North Carolina, United States
Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
🇺🇸Los Angeles, California, United States