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A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
Study Purpose
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve
participants with newly diagnosed IPF.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Male or female subject of age 40 years or older.
2. Willing and able to provide written informed consent.
3. Diagnosis of IPF within 3 years of Screening as confirmed by HRCT of chest or lung
biopsy as defined by ATS/ERS/JRS/ALAT guideline.
4. Forced vital capacity (FVC) percent predicted ≥ 40%.
5. Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and
≤ 80.
6. Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.
Exclusion Criteria:
1. Interstitial lung disease other than IPF.
2. Evidence of significant obstructive lung disease.
3. Current diagnosis of asthma.
4. Treatment with an approved or investigational antifibrotic therapy for IPF within 2
months of the Baseline bronchoscopy.
5. Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and
throughout the Treatment Period.
6. Inability to use study inhaler device appropriately.
7. Pulmonary exacerbation within 6 months prior to Screening.
8. Febrile illness within 7 days prior to dosing.
9. Participation in a clinical study or treatment with an investigational drug or device
within 30 days of the Screening Visit (or 5 half-lives of the investigational agent,
whichever is longer).
10. History or evidence at screening of significant renal impairment with eGFR < 30 mL/min
(region specific).
11. 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 (region specific).
12. Serious or active medical or psychiatric condition which, in the opinion of the
Investigator, may interfere with treatment, assessment, or compliance with the
protocol.
13. Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment
Period.
14. Subject has severe progressive or uncontrolled, clinically significant disease that in
the judgment of the investigator or designee renders the subject unsuitable for the
study.
15. Positive urine pregnancy test in female subjects of childbearing potential as defined
below.
16. Female subjects who are lactating.
17. 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
subjects who do not agree to refrain from donating sperm during this same period.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 1
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Lung Therapeutics, Inc
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Steven A. Shoemkaer, MD
Principal Investigator Affiliation
Lung Therapeutics
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Germany, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Additional Details
This is a randomized, double-blind, placebo controlled, multi-center, dose escalation, safety
and tolerability study of LTI-03 or placebo administered by inhalation in participants
recently diagnosed with idiopathic pulmonary fibrosis that have not received prior treatment
with anti-fibrotic agents.
The study will contain 2 dose cohorts which will run sequentially.
Eligible participants will be randomized in a 3:1 ratio to either LTI-03 or placebo. Safety
data will be reviewed on an ongoing basis. Enrollment in the second cohort will not begin
until the Cohort 1 safety data has been reviewed.
The Treatment Period will be 14 days, with subjects self-administering study drug using a
provided commercially available dry-powder inhaler.
Arms & Interventions
Arms
Experimental: 2.5 mg LTI-03 BID
2.5 mg LTI-03 BID x 14 days
Experimental: 5 mg LTI-03 BID
5 mg LTI-03 BID x 14 days
Placebo Comparator: Placebo
Matching placebo BID x 14 days
Interventions
Drug: - LTI-03
Caveolin-1-Scaffolding-Protein-Derived Peptide
Drug: - Placebo
Matching placebo
Contact a Trial Team
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