Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
Purpose
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.
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 2:1 randomization PLN-74809:placebo
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- double-blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PLN-74809 |
160 mg PLN-74809 |
|
|
Placebo Comparator Placebo |
Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT05621252
- Status
- Completed
- Sponsor
- Pliant Therapeutics, Inc.
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.