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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
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)
Secondary ID [1] 0 0
INTEGRIS-IPF
Secondary ID [2] 0 0
PLN-74809-IPF-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A - Number of Participants With Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Up to 4 weeks
Primary outcome [2] 0 0
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
Timepoint [2] 0 0
Up to 12 weeks
Primary outcome [3] 0 0
Part D - Number of Participants With Treatment-Emergent Adverse Events
Timepoint [3] 0 0
Up to 48 weeks
Primary outcome [4] 0 0
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
Timepoint [4] 0 0
Up to 4 weeks
Primary outcome [5] 0 0
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
Timepoint [5] 0 0
Up to 12 weeks
Primary outcome [6] 0 0
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Part A - Assessment of PLN-74809 Total Plasma Concentrations
Timepoint [1] 0 0
Week 4, 1 Hour Post Dose
Secondary outcome [2] 0 0
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
Timepoint [2] 0 0
Week 12, 2 Hours Post Dose
Secondary outcome [3] 0 0
Part D - Assessment of PLN-74809 Total Plasma Concentrations
Timepoint [3] 0 0
Week 24, 2 Hours Post Dose

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2023
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Italy
State/province [14] 0 0
Milan
Country [15] 0 0
Netherlands
State/province [15] 0 0
EJ
Country [16] 0 0
Netherlands
State/province [16] 0 0
SZ
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
New Zealand
State/province [18] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pliant Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pliant Therapeutics Medical Monitor
Address 0 0
Pliant Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04396756