NCT04396756Phase 2Completed

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

Study sponsor: Pliant Therapeutics, Inc. · PLRX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-02-01Actual

Enrollment · participants120Actual

Source updated2024-06-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Idiopathic Pulmonary Fibrosis

Treatments or interventions studied

PLN-74809Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Part A - Number of Participants With Treatment-Emergent Adverse Events; description: 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.; timeFrame: Up to 4 weeks; measure: Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events; description: 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.; timeFrame: Up to 12 weeks; measure: Part D - Number of Participants With Treatment-Emergent Adverse Events; description: 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.; timeFrame: Up to 48 weeks; measure: Part A - Number of Participants With Serious Treatment-Emergent Adverse Events; description: 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.; timeFrame: Up to 4 weeks; measure: Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events; description: 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.; timeFrame: Up to 12 weeks; measure: Part D - Number of Participants With Serious Treatment-Emergent Adverse Events; description: 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.; timeFrame: Up to 48 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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