Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/ (IPF-201)

A 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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: PLN-74809; Radiation: Knottin tracer

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLN-74809 Dose Level 1 (60 mg); PLN-74809 Dose Level 1 (60mg)	Drug: PLN-74809; PLN-74809; Radiation: Knottin tracer; Radiotracer
Experimental: PLN-74809 Dose Level 2 (80 mg)	Drug: PLN-74809; PLN-74809; Radiation: Knottin tracer; Radiotracer
Experimental: PLN-74809 Dose Level 3 (120 mg)	Drug: PLN-74809; PLN-74809; Radiation: Knottin tracer; Radiotracer
Experimental: PLN-74809 Dose Level 4 (240 mg)	Drug: PLN-74809; PLN-74809; Radiation: Knottin tracer; Radiotracer
Experimental: PLN-74809 Dose Level 4 (320 mg)	Drug: PLN-74809; PLN-74809; Radiation: Knottin tracer; Radiotracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.	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.	Following 1 day of dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events	Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14).	From screening to 1 week following the administration of PLN-74809

Other Outcome Measures

Outcome Measure	Time Frame
Relationship between PLN-74809 systemic exposure, αvβ6 receptor occupancy and biomarkers in IPF participants	Following 1 day of administration of PLN-74809

Collaborators and Investigators

• Sponsor: Pliant Therapeutics, Inc.
• Collaborators: Stanford University
• Investigators: Study Director: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: PLN-74809-IPF-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No