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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04396756
Registration number
NCT04396756
Ethics application status
Date submitted
6/05/2020
Date registered
21/05/2020
Titles & IDs
Public title
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
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Scientific 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)
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Secondary ID [1]
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INTEGRIS-IPF
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Secondary ID [2]
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PLN-74809-IPF-202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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0
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Connective tissue diseases
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PLN-74809
Treatment: Drugs - Placebo
Experimental: Placebo - Placebo
Experimental: PLN-74809 Dose Level 1 (Part A) - PLN-74809 Dose Level 1 (Part A) - 4 weeks
Experimental: PLN-74809 Dose Level 2 (Part A) - PLN-74809 Dose Level 2 (Part A) - 4 weeks
Experimental: PLN-74809 Dose Level 2 (Part B) - PLN-74809 Dose Level 2 (Part B) - 12 weeks
Experimental: PLN-74809 - Dose Level 3 (Part C) - PLN-74809 Dose Level 3 (Part C) - 12 weeks
Experimental: PLN-74809 - Dose Level 4 (Part C) - PLN-74809 Dose Level 4 (Part C) - 12 weeks
Experimental: PLN-74809 - Dose Level 5 (Part D) - PLN-74809 Dose Level 5 (Part D) - = 24 weeks
Treatment: Drugs: PLN-74809
PLN-74809
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A - Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 4 weeks
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Primary outcome [2]
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Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 12 weeks
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Primary outcome [3]
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Part D - Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 48 weeks
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Primary outcome [4]
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Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 4 weeks
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Primary outcome [5]
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Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 12 weeks
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Primary outcome [6]
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Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 48 weeks
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Secondary outcome [1]
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Part A - Assessment of PLN-74809 Total Plasma Concentrations
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Assessment method [1]
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Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose
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Timepoint [1]
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Week 4, 1 Hour Post Dose
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Secondary outcome [2]
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Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
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Assessment method [2]
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Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose
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Timepoint [2]
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Week 12, 2 Hours Post Dose
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Secondary outcome [3]
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Part D - Assessment of PLN-74809 Total Plasma Concentrations
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Assessment method [3]
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Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose
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Timepoint [3]
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Week 24, 2 Hours Post Dose
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/02/2023
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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Country [9]
0
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United States of America
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State/province [9]
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Tennessee
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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Belgium
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State/province [11]
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Leuven
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Country [12]
0
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Canada
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State/province [12]
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Ontario
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Country [13]
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Canada
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State/province [13]
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Quebec
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Country [14]
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Italy
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State/province [14]
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Milan
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Country [15]
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Netherlands
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State/province [15]
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EJ
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Country [16]
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Netherlands
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State/province [16]
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SZ
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Country [17]
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New Zealand
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State/province [17]
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Auckland
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Country [18]
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New Zealand
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State/province [18]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pliant Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04396756
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pliant Therapeutics Medical Monitor
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Address
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Pliant Therapeutics, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/56/NCT04396756/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT04396756/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04396756