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

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: PLN-74809
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 % of 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: PLN-74809 Dose Level 1 (Part A)<br>PLN-74809 Dose Level 1 (Part A) - 4 weeks | Drug: PLN-74809<br>* PLN-74809<br>|
| Experimental: PLN-74809 Dose Level 2 (Part A)<br>PLN-74809 Dose Level 2 (Part A) - 4 weeks | Drug: PLN-74809<br>* PLN-74809<br>|
| Experimental: PLN-74809 Dose Level 2 (Part B)<br>PLN-74809 Dose Level 2 (Part B) - 12 weeks | Drug: PLN-74809<br>* PLN-74809<br>|
| Experimental: PLN-74809 - Dose Level 3 (Part C)<br>PLN-74809 Dose Level 3 (Part C) - 12 weeks | Drug: PLN-74809<br>* PLN-74809<br>|
| Experimental: PLN-74809 - Dose Level 4 (Part C)<br>PLN-74809 Dose Level 4 (Part C) - 12 weeks | Drug: PLN-74809<br>* PLN-74809<br>|
| Experimental: PLN-74809 - Dose Level 5 (Part D)<br>PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks | Drug: PLN-74809<br>* PLN-74809<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A, B & C - Assessment of PLN-74809 plasma concentrations |  | Up to 12 weeks | 
| Part D - Assessment of PLN-74809 plasma concentrations |  | Up to 24 weeks |