Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Purpose
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.
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Placebo |
Placebo |
|
|
Experimental PLN-74809 Dose Level 1 (Part A) |
PLN-74809 Dose Level 1 (Part A) - 4 weeks |
|
|
Experimental PLN-74809 Dose Level 2 (Part A) |
PLN-74809 Dose Level 2 (Part A) - 4 weeks |
|
|
Experimental PLN-74809 Dose Level 2 (Part B) |
PLN-74809 Dose Level 2 (Part B) - 12 weeks |
|
|
Experimental PLN-74809 - Dose Level 3 (Part C) |
PLN-74809 Dose Level 3 (Part C) - 12 weeks |
|
|
Experimental PLN-74809 - Dose Level 4 (Part C) |
PLN-74809 Dose Level 4 (Part C) - 12 weeks |
|
|
Experimental PLN-74809 - Dose Level 5 (Part D) |
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks |
|
Recruiting Locations
More Details
- NCT ID
- NCT04396756
- Status
- Completed
- Sponsor
- Pliant Therapeutics, Inc.
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