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

Idiopathic Pulmonary Fibrosis Clinical Trial

— IPF-201  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072315
• Other study ID #: PLN-74809-IPF-201
• Status: Completed
• Phase: Phase 2
• Start date: February 13, 2020
• Est. completion date: July 5, 2022

Study information

• Verified date: November 2023
• Source: Pliant Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 5, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• PLN-74809
PLN-74809

Radiation:
• Knottin tracer
Radiotracer

Locations

Country	Name	City	State
United States	Stanford Medical Center	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Pliant Therapeutics, Inc.	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Predicted Effect on aVß6 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 avß6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.	Following 1 day of dosing
Secondary	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