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

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT04396756

Run by

Pliant Therapeutics, Inc.

People needed

120

Starts

2020-03-03

Expected to finish

2023-02-15

Last updated by the study team

2024-06-03

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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