Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT04396756
Last Updated: 2024-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2020-03-03
2023-02-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Placebo
PLN-74809 Dose Level 1 (Part A)
PLN-74809 Dose Level 1 (Part A) - 4 weeks
PLN-74809
PLN-74809
PLN-74809 Dose Level 2 (Part A)
PLN-74809 Dose Level 2 (Part A) - 4 weeks
PLN-74809
PLN-74809
PLN-74809 Dose Level 2 (Part B)
PLN-74809 Dose Level 2 (Part B) - 12 weeks
PLN-74809
PLN-74809
PLN-74809 - Dose Level 3 (Part C)
PLN-74809 Dose Level 3 (Part C) - 12 weeks
PLN-74809
PLN-74809
PLN-74809 - Dose Level 4 (Part C)
PLN-74809 Dose Level 4 (Part C) - 12 weeks
PLN-74809
PLN-74809
PLN-74809 - Dose Level 5 (Part D)
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
PLN-74809
PLN-74809
Interventions
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PLN-74809
PLN-74809
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Pliant Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pliant Therapeutics Medical Monitor
Role: STUDY_DIRECTOR
Pliant Therapeutics, Inc.
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
Los Angeles, California, United States
Yale University Scool of Medicine/ Yale New Haven Hospital
New Haven, Connecticut, 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
UPMC
Pittsburgh, Pennsylvania, United States
Vanderbilt Lung Institute at One Hundred Oaks
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
UZ Leuven
Leuven, , Belgium
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Ontario, Canada
CISSS de la Montérégie Centre
Greenfield Park, Quebec, Canada
San Giuseppe Hospital, Multimedica S.p.a.
Milan, , Italy
Catharina Ziekenhuis
Eindhoven, EJ, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, SZ, Netherlands
New Zealand Respiratory and Sleep Institute
Greenlane, Auckland, New Zealand
University of Otago Christchurch
Christchurch, , New Zealand
Countries
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References
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Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INTEGRIS-IPF
Identifier Type: OTHER
Identifier Source: secondary_id
PLN-74809-IPF-202
Identifier Type: -
Identifier Source: org_study_id
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