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

• ClinicalTrials.gov Identifier: NCT05621252
• Recruitment Status: Completed
• First Posted: November 18, 2022
• Last Update Posted: February 9, 2024
• Sponsor: Pliant Therapeutics, Inc.
• Information provided by (Responsible Party): Pliant Therapeutics, Inc.

Tracking Information

• First Submitted Date: November 2, 2022
• First Posted Date: November 18, 2022
• Last Update Posted Date: February 9, 2024
• Actual Study Start Date: July 13, 2022
• Actual Primary Completion Date: December 27, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 14, 2022)

Primary Outcome [ Time Frame: 12 weeks ]

Number of participants with a change in Baseline of type 1 collagen in the lung following 12 weeks of treatment with PLN-74809, as assessed by changes from Baseline in 68Ga-CBP8 (PET)/(MRI) tracer uptake patterns

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 14, 2022)

Secondary Safety and Tolerability [ Time Frame: From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose ]

Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 27, 2023)

• Exploratory 1 [ Time Frame: 12 weeks ]
  Forced vital capacity (FVC): absolute FVC volume and FVC as percent of predicted as assessed by spirometry
• Exploratory 2 [ Time Frame: 12 weeks ]
  Patient-reported outcome (PRO): Cough Severity Visual Analog Scale (VAS) records patients' assessment of cough severity on a 100-mm linear scale ranging from "no cough" (0mm) to "worst cough" (100mm). Higher score means worse outcome.

Original Other Pre-specified Outcome Measures (submitted: November 14, 2022)

• Exploratory 1 [ Time Frame: 12 weeks ]
  Forced vital capacity (FVC): absolute FVC volume and FVC as percent of predicted as assessed by spirometry
• Exploratory 2 [ Time Frame: 12 weeks ]
  Patient-reported outcome (PRO): a visual analog scale (VAS) for cough severity

Descriptive Information

• Brief Title: Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
• Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)
• 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.

Detailed Description

This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period.

Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2:1 randomization PLN-74809:placebo

Masking: Double (Participant, Investigator)
Masking Description:

double-blind

Primary Purpose: Treatment

• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: PLN-74809
  160 mg PLN-74809
• Drug: Placebo
  Matching placebo

Study Arms

• Experimental: PLN-74809
  160 mg PLN-74809
  Intervention: Drug: PLN-74809
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2024): 10
• Original Estimated Enrollment (submitted: November 14, 2022): 12
• Actual Study Completion Date: January 8, 2024
• Actual Primary Completion Date: December 27, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05621252
• Other Study ID Numbers: PLN-74809-IPF-205
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pliant Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pliant Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sydney Montesi, MD; Mass. General Hospital

• PRS Account: Pliant Therapeutics, Inc.
• Verification Date: February 2024