Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

• ClinicalTrials.gov Identifier: NCT04396756
• Recruitment Status: Active, not recruiting
• First Posted: May 21, 2020
• Last Update Posted: August 18, 2022
• Sponsor: Pliant Therapeutics, Inc.
• Information provided by (Responsible Party): Pliant Therapeutics, Inc.

Tracking Information

• First Submitted Date: May 6, 2020
• First Posted Date: May 21, 2020
• Last Update Posted Date: August 18, 2022
• Actual Study Start Date: March 3, 2020
• Estimated Primary Completion Date: February 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 31, 2022)

• Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 28 days ]
• Part B & C - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 12 weeks ]
• Part D - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 48 weeks ]

Original Primary Outcome Measures (submitted: May 15, 2020)

• Part A - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 28 days ]
• Part B & C - Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: Up to 12 weeks ]

Current Secondary Outcome Measures (submitted: May 31, 2022)

• Part A, B & C - Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 12 weeks ]
• Part D - Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 24 weeks ]

• Original Secondary Outcome Measures (submitted: May 15, 2020): Assessment of PLN-74809 plasma concentrations [ Time Frame: Up to 12 weeks ]

Current Other Pre-specified Outcome Measures (submitted: May 31, 2022)

• Part A - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 28 days ]
• Part B & C - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 12 weeks ]
• Part D - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 48 weeks ]
• Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12 [ Time Frame: Up to 12 weeks ]
• Part D - Change in pulmonary fibrosis score by quantitative HRCT at Week 24 [ Time Frame: Up to 24 weeks ]
• Part B & C - Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 12 weeks ]
• Part D - Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 48 weeks ]

Original Other Pre-specified Outcome Measures (submitted: May 15, 2020)

• Part A - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 28 days ]
• Part B & C - Assessment of change from baseline in forced vital capacity (FVC) [ Time Frame: Up to 12 weeks ]
• Part B & C - Change in pulmonary fibrosis score by quantitative HRCT at Week 12 [ Time Frame: Up to 12 weeks ]
• Assessment of change from baseline in a visual analog scale (VAS) scale for cough [ Time Frame: Up to 12 weeks ]

Descriptive Information

• Brief Title: Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
• Official Title: A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)
• Brief Summary: A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Detailed Description

Four part study:

Part A - 4 week treatment period evaluating PLN-74809 or matching placebo

Part B - 12 week treatment period evaluating PLN-74809 or matching placebo

Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo

Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: PLN-74809
  PLN-74809
• Drug: Placebo
  Placebo

Study Arms

• Experimental: Placebo
  Placebo
  Intervention: Drug: Placebo
• Experimental: PLN-74809 Dose Level 1 (Part A)
  PLN-74809 Dose Level 1 (Part A) - 4 weeks
  Intervention: Drug: PLN-74809
• Experimental: PLN-74809 Dose Level 2 (Part A)
  PLN-74809 Dose Level 2 (Part A) - 4 weeks
  Intervention: Drug: PLN-74809
• Experimental: PLN-74809 Dose Level 2 (Part B)
  PLN-74809 Dose Level 2 (Part B) - 12 weeks
  Intervention: Drug: PLN-74809
• Experimental: PLN-74809 - Dose Level 3 (Part C)
  PLN-74809 Dose Level 3 (Part C) - 12 weeks
  Intervention: Drug: PLN-74809
• Experimental: PLN-74809 - Dose Level 4 (Part C)
  PLN-74809 Dose Level 4 (Part C) - 12 weeks
  Intervention: Drug: PLN-74809
• Experimental: PLN-74809 - Dose Level 5 (Part D)
  PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
  Intervention: Drug: PLN-74809

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 17, 2022): 120
• Original Estimated Enrollment (submitted: May 15, 2020): 84
• Estimated Study Completion Date: March 30, 2023
• Estimated Primary Completion Date: February 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C & D)
• FVC %predicted ≥45%
• DLco (hemoglobin-adjusted) ≥30%
• 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 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
• Gender Based Eligibility: Yes

• 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: Australia, Belgium, Canada, Italy, Netherlands, New Zealand, United States

Administrative Information

• NCT Number: NCT04396756
• Other Study ID Numbers: PLN-74809-IPF-202; INTEGRIS-IPF ( Other Identifier: Pliant Therapeutics )
• Has Data Monitoring Committee: Yes

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

• Study Director: Pliant Therapeutics Medical Monitor; Pliant Therapeutics, Inc.

• PRS Account: Pliant Therapeutics, Inc.
• Verification Date: April 2022