Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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; 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PLN-74809 160 mg PLN-74809 |
Drug: PLN-74809
160 mg PLN-74809
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- Primary Outcome [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
Secondary Outcome Measures
- Secondary Safety and Tolerability [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.
Other Outcome Measures
- Exploratory 1 [12 weeks]
Forced vital capacity (FVC): absolute FVC volume and FVC as percent of predicted as assessed by spirometry
- Exploratory 2 [12 weeks]
Patient-reported outcome (PRO): a visual analog scale (VAS) for cough severity
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Pliant Therapeutics, Inc.
Investigators
- Principal Investigator: Sydney Montesi, MD, Mass. General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLN-74809-IPF-205