Testing LTI-03 for treating Idiopathic Pulmonary Fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of LTI-03, an experimental medication administered via inhaler, for patients with Idiopathic Pulmonary Fibrosis (IPF). The study aims to determine if LTI-03 can improve lung function and reduce lung scarring compared to a placebo. Participants must have been diagnosed with IPF within the last five years and may continue stable treatment with certain existing medications. The trial will assess both the side effects of LTI-03 and its potential benefits in alleviating symptoms of IPF.

Why it matters

Who can join: the full rules

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.

Where it's running

• UAB Lung Health Center
  Birmingham, Alabama, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Paradigm Clinical Research Centers, LLC
  San Diego, California, United States Recruiting
• National Jewish Health
  Denver, Colorado, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Steven A. Shoemaker, MD
• Email: sshoemaker@nicosof.com
• Phone: 720-560-2167

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nerandomilast in IPF and Progressive Fibrosis: Real-World Data

  This study tests whether nerandomilast helps slow lung function decline in adults with IPF or progressive fibrotic lung disease in routine clinical care.

  Recruiting at 4 sites Tel Aviv Medical Center · Ashkelon and 3 other locations · NCT07919015

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Finger vs. Earlobe Pulse Oximetry During a 6-Minute Walk Test in ILD

  This study tests whether finger or earlobe pulse oximetry gives the same oxygen saturation readings during a 6-minute walk in people with interstitial lung disease.

  Recruiting Hospital de Granollers · Granollers, Spain · NCT07723872

• Biomarker clues for COPD, IPF, and lung cancer

  This study tests whether inflammation, immune, genetic, and epigenetic markers at enrollment can explain how COPD, IPF, or lung cancer present and behave, in order to see if these markers can predict outcomes over a year.

  Recruiting Fondazione Don Carlo Gnocchi ETS · Milan, Milan · NCT07707245

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

• AZD8965 in IPF: see if three doses help IPF patients

  This Phase IIb study tests three doses of AZD8965 against placebo in people with idiopathic pulmonary fibrosis, including those who are and aren’t on antifibrotic therapy.

  Recruiting at 103 sites Phase 2 AstraZeneca · Birmingham, Alabama and 197 other locations · NCT07652658

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.