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New treatment option for Idiopathic Pulmonary Fibrosis (IPF)
Official title A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT06968845
What this study is testing
What is LTI-03?
LTI-03 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis (ipf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Male or female age 40 years or older.
- Willing and able to provide written informed consent.
- Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT...
- Forced vital capacity (FVC) percent predicted ≥ 45% at Screening.
- Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
You likely can't join if
- Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7 at Screening.
- Use of N-acetyl cysteine or other supplements including but not limited to quercetin, omega-3 fatty acids, dehydroepiandrosterone, polyphenols, and...
- Use of systemic corticosteroids at doses \> 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
- Active smoker.
- Pulmonary exacerbation within 3 months prior to Screening.
- Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.
See the full eligibility criteria
- Male or female age 40 years or older.
- Willing and able to provide written informed consent.
- Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT lung fibrosis by central read during screening must involve ≥ 10% of the...
- Forced vital capacity (FVC) percent predicted ≥ 45% at Screening.
- Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
- Participants receiving nintedanib, pirfenidone, or nerandomilast (where approved for marketing) for IPF treatment must have been on a stable prescribed dose for at least 12 weeks prior to Randomization.
- Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization.
- Able to adequately self-administer study drug using the protocol-specified inhaler device.
- Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7 at Screening.
- Use of N-acetyl cysteine or other supplements including but not limited to quercetin, omega-3 fatty acids, dehydroepiandrosterone, polyphenols, and phytochemicals within 7 days prior to Randomization and through Week 24.
- Use of systemic corticosteroids at doses \> 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
- Active smoker.
- Pulmonary exacerbation within 3 months prior to Screening.
- Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.
- Participation in a clinical study or treatment with an investigational drug or device within 28 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer).
- History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2.
- History or evidence at Screening of significant hepatic impairment with bilirubin \> 3 mg/dL (\> 51.3 μmol/L) and albumin \ 6 sec or INR \> 2.3 while not on anticoagulant medication.
- Active or history of malignancies within 5 years prior to Randomization, with the exception of localized nonmetastatic basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer.
- Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol; or an expected survival of less than 24 weeks...
- Positive pregnancy test in female participants of childbearing potential (defined below).
- Female participants who are lactating.
- Females of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Weston, Florida, United States
- Detroit, Michigan, United States
- Chesterfield, Missouri, United States
- Kansas City, Missouri, United States
- Chapel Hill, North Carolina, United States
- Charleston, South Carolina, United States
- El Paso, Texas, United States
- Salt Lake City, Utah, United States
- Westmead, New South Wales, Australia
- Launceston, Tasmania, Australia
- Warsaw, Poland, Poland
- Sosnowiec, Silesian Voivodeship, Poland
- Trumpington, Cambridge, United Kingdom
- Exeter, Devon, United Kingdom
- Edinburgh, Scotland, United Kingdom
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; San Diego, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Weston, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.