Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients With Idiopathic Pulmonary Fibrosis
Led by Rein Therapeutics · Updated on 2026-06-05
120
Participants Needed
16
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying LTI-03, an experimental inhaled medication, for treating Idiopathic Pulmonary Fibrosis (IPF), a progressive and fatal lung disease characterized by lung cell death and scarring. The study aims to evaluate LTI-03's safety, side effects, impact on lung scarring, and symptom improvement. The trial includes patients diagnosed with IPF within the last five years, some of whom may be on stable doses of approved IPF treatments like nintedanib, pirfenidone, or nerandomilast. Participants will be randomly assigned to receive either LTI-03 or a placebo via a dry powder inhaler, self-administered twice daily. The study is a Phase 2, randomized, double-blind, placebo-controlled trial with a 28-day screening period, a 24-week treatment phase, and a 4-week follow-up. Approximately 120 participants will be involved, with lung scans conducted at the start and end of treatment to measure fibrosis changes. Throughout up to nine clinic visits, participants will undergo physical exams, vital sign checks, heart monitoring, blood tests, lung function tests, and lung diffusion capacity tests. They will complete questionnaires about their symptoms and safety evaluations. Researchers will monitor lung function, disease biomarkers, and side effects to assess the treatment's safety and effectiveness over the course of the study.
CONDITIONS
Brief Title
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 40 years or older
- Willing and able to provide written informed consent
- Diagnosis of Idiopathic Pulmonary Fibrosis within 5 years confirmed by central lung scan showing at least 10% lung fibrosis
- Forced vital capacity (FVC) percent predicted 45% or higher at screening
- Diffusion capacity of lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted 30% or higher within 8 weeks before randomization
- If taking nintedanib, pirfenidone, or nerandomilast, must be on a stable dose for at least 12 weeks before randomization
- If previously treated with these drugs, must have stopped at least 8 weeks before randomization
- Able to self-administer study drug using the inhaler device
You will not qualify if you...
- Forced expiratory volume in 1 second (FEV1)/FVC ratio less than 0.7 at screening
- Use of N-acetyl cysteine or certain supplements within 7 days before randomization and through week 24
- Use of systemic corticosteroids over 10 mg/day prednisone or equivalent within 28 days before randomization
- Active smoker
- Pulmonary exacerbation within 3 months before screening
- Feverish lung infection needing antibiotics within 28 days before randomization
- Participation in another clinical trial or use of investigational drug/device within 28 days before screening
- Significant kidney impairment with estimated filtration rate under 30 mL/min/1.73m2
- Significant liver impairment by blood tests at screening
- Active or recent cancer within 5 years except some skin or cervical cancers
- Serious medical or psychiatric condition that may interfere with study or expected survival less than 24 weeks
- Positive pregnancy test in females of childbearing potential
- Lactating females
- Females and males with partners of childbearing potential not agreeing to use contraception during treatment and 90 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive the study drug or placebo using a dry powder inhaler to evaluate safety, tolerability, and efficacy.
Regular visits during treatment up to Week 24
Trial Site Locations
Total: 16 locations
1
UAB Lung Health Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Paradigm Clinical Research Centers, LLC
San Diego, California, United States, 92108
Actively Recruiting
3
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
4
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
6
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
7
The Lung Research Center, LLC
Chesterfield, Missouri, United States, 63017
Actively Recruiting
8
University of Kansas Medical Center
Kansas City, Missouri, United States, 66160
Actively Recruiting
9
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
El Paso Pulmonary Association
El Paso, Texas, United States, 79902
Actively Recruiting
12
Launceston Respiratory and Sleep Centre
Launceston, Tasmania, Australia, 7250
Actively Recruiting
13
Salus Aegroti Praktyka Lekarska dr n. med. Grzegorz Gąsior
Sosnowiec, Silesian Voivodeship, Poland, 41-208
Actively Recruiting
14
Royal Papworth Hospital
Trumpington, Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
15
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom, EX2 5DW
Actively Recruiting
16
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Actively Recruiting
Research Team
S
Steven A. Shoemaker, MD
S
Shawna H. Evans
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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