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A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis

RecruitingPhase 2Ages 40 Years - anyAllRein Therapeutics
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In plain words

What the trial is, and whether it could suit you

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 d

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female age 40 years or older. 2. Willing and able to provide written informed consent. 3. 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 lung and be greater than emphysema involvement of the lung. 4. Forced vital capacity (FVC) percent predicted ≥ 45% at Screening. 5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization. 6. 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. 7. Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization. 8. Able to adequately self-administer study drug using the protocol-specified inhaler device. Exclusion Criteria: 1. Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7 at Screening. 2. 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. 3. Use of systemic corticosteroids at doses \> 10 mg/day of prednisone or equivalent within 28 days prior to Randomization. 4. Active smoker. 5. Pulmonary exacerbation within 3 months prior to Screening. 6. Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization. 7. 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). 8. History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2. 9. History or evidence at Screening of significant hepatic impairment with bilirubin \> 3 mg/dL (\> 51.3 μmol/L) and albumin \< 2.8 g/dL (\<28 g/L) and PT prolongation \> 6 sec or INR \> 2.3 while not on anticoagulant medication. 10. 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. 11. 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. Contraception and Pregnancy 12. Positive pregnancy test in female participants of childbearing potential (defined below). 13. Female participants who are lactating. 14. 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 last dose of study drug. Male participants who do not agree to refrain from donating sperm during this same period.
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What it tests

  • LTI-03
  • Dry Powder Inhaler
  • Placebo
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Where

48 sites
UAB Lung Health Center
Birmingham, United States
University of Southern California
Los Angeles, United States
Cedars Sinai Medical Center
Los Angeles, United States
Paradigm Clinical Research Centers, LLC
San Diego, United States
National Jewish Health
Denver, United States
Yale University School of Medicine
New Haven, United States
Cleveland Clinic Florida
Weston, United States
Indiana University
Indianapolis, United States

…and 40 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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