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Completed

NCT Number: NCT04072315

Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/

A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Medical Center

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of IPF, within 5 years prior to Screening,
  • FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
  • DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
  • Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months

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
  • 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

Treatment and study plan

PLN-74809

Drug

PLN-74809

Knottin tracer

Radiation

Radiotracer

Primary outcomes

  1. Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.

    Time frame: Following 1 day of dosing

    Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.

Secondary outcomes

  1. Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events

    Time frame: From screening to 1 week following the administration of PLN-74809

    Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14).

Sponsors and collaborators

Lead sponsor

Pliant Therapeutics, Inc.

Industry

Collaborators

  • Stanford University

Registry information

Official study title

A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF

Acronym: IPF-201

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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