Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)

NCT05621252 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PLN-74809-IPF-205
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung.

  12 weeks

Secondary Outcomes (1)

• Secondary Safety and Tolerability

  From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose

Other Outcomes (2)

• Exploratory 1

  12 weeks

• Exploratory 2

  12 weeks

Study Arms (2)

PLN-74809

EXPERIMENTAL

160 mg PLN-74809

Drug: PLN-74809

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PLN-74809 DRUG

160 mg PLN-74809

PLN-74809

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants, aged 40 years or older
• Diagnosis of IPF, within 8 years prior to Screening
• FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
• Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
• Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, 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

Sponsors & Collaborators

• Pliant Therapeutics, Inc.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Montesi SB, Cosgrove GP, Turner SM, Zhou IY, Efthimiou N, Susnjar A, Catana C, Fromson C, Clark A, Decaris M, Barnes CN, Lefebvre EA, Caravan P. Dual alphavbeta6 and alphavbeta1 Inhibition over 12 Weeks Reduces Active Type I Collagen Deposition in Individuals with Idiopathic Pulmonary Fibrosis: A Phase 2, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1229-1240. doi: 10.1164/rccm.202410-1934OC.

  PMID: 40153543 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: Pliant Therapeutics Medical Monitor
• Organization: Pliant Therapeutics

clintrials@pliantrx.com

650-481-6770

Study Officials

• Sydney Montesi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization PLN-74809:placebo

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 18, 2022
• Study Start: July 13, 2022
• Primary Completion: December 27, 2023
• Study Completion: January 8, 2024
• Last Updated: December 5, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)