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

NCT04072315 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PLN-74809-IPF-201
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Study Arms (5)

PLN-74809 Dose Level 1 (60 mg)

EXPERIMENTAL

PLN-74809 Dose Level 1 (60mg)

Drug: PLN-74809; Radiation: Knottin tracer

PLN-74809 Dose Level 2 (80 mg)

EXPERIMENTAL

PLN-74809 Dose Level 2 (80 mg)

Drug: PLN-74809; Radiation: Knottin tracer

PLN-74809 Dose Level 3 (120 mg)

EXPERIMENTAL

PLN-74809 Dose Level 3 (120 mg)

Drug: PLN-74809; Radiation: Knottin tracer

PLN-74809 Dose Level 4 (240 mg)

EXPERIMENTAL

PLN-74809 Dose Level 4 (240 mg)

Drug: PLN-74809; Radiation: Knottin tracer

PLN-74809 Dose Level 4 (320 mg)

EXPERIMENTAL

PLN-74809 Dose Level 4 (320 mg)

Drug: PLN-74809; Radiation: Knottin tracer

Interventions

PLN-74809 DRUG

PLN-74809

PLN-74809 Dose Level 1 (60 mg); PLN-74809 Dose Level 2 (80 mg); PLN-74809 Dose Level 3 (120 mg); PLN-74809 Dose Level 4 (240 mg); PLN-74809 Dose Level 4 (320 mg)

Knottin tracer RADIATION

Radiotracer

PLN-74809 Dose Level 1 (60 mg); PLN-74809 Dose Level 2 (80 mg); PLN-74809 Dose Level 3 (120 mg); PLN-74809 Dose Level 4 (240 mg); PLN-74809 Dose Level 4 (320 mg)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Pliant Therapeutics, Inc.: lead
• Stanford University: collaborator

Study Sites (1)

Stanford Medical Center

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• Mooney JJ, Jacobs S, Lefebvre EA, Cosgrove GP, Clark A, Turner SM, Decaris M, Barnes CN, Jurek M, Williams B, Duan H, Kimura R, Rizzo G, Searle G, Wardak M, Guo HH. Bexotegrast Shows Dose-Dependent Integrin alphavbeta6 Receptor Occupancy in Lungs of Participants with Idiopathic Pulmonary Fibrosis: A Phase 2, Open-Label Clinical Trial. Ann Am Thorac Soc. 2025 Mar;22(3):350-358. doi: 10.1513/AnnalsATS.202409-969OC.

  PMID: 39499805 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Éric Lefebvre, M.D., Chief Medical Officer
• Organization: Pliant Therapeutics, Inc.

ELefebvre@pliantrx.com

1-650-481-6779

Study Officials

• Pliant Therapeutics Medical Monitor

  Pliant Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, incomplete crossover, up to 2 single doses administered at two different times

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: February 13, 2020
• Primary Completion: June 27, 2022
• Study Completion: July 5, 2022
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)