Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring. The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate. Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period. Study Assessments: Up to 9 visits to the study clinic will be required. Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler. Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only. Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis. Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Caveolin-1-Scaffolding-Protein-Derived Peptide
Plastiape Monodose RS01 Model 7
Lactose powder
UAB Lung Health Center
Birmingham, Alabama, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGParadigm Clinical Research Centers, LLC
San Diego, California, United States
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Week 24
Change from baseline in forced vital capacity (FVC)
Time frame: Day 1 through Week 24
Change from baseline in percent predicted FVC
Time frame: Day 1 through Week 24
Change from baseline in lung fibrosis measured by high resolution computed tomography (HRCT)
Time frame: Day 1 through Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
National Jewish Health
Denver, Colorado, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGHenry Ford Health
Detroit, Michigan, United States
RECRUITING...and 26 more locations