- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05954988
A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Sydney Kruger, MS
- Phone Number: 4109672905
- Email: skruger@lungtx.com
Study Locations
-
-
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Gießen, Germany
- Not yet recruiting
- Agaplesion Evangelisches Krankenhaus Mittelhessen
-
Contact:
- Olga Maurer
-
-
-
-
-
Edinburgh, United Kingdom
- Recruiting
- University of Edinburgh
-
Contact:
- Sarah McNamara
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London, United Kingdom, SW3 6HP
- Recruiting
- Royal Brompton Hospital
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Contact:
- Patricia Duarte
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Newcastle, United Kingdom
- Recruiting
- Royal Victoria Infirmary
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Contact:
- Ana Alvarex Franco
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-
-
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama
-
Contact:
- Andrea Ford
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California
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars Sinai Medical Center
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Contact:
- Emad Bayoumi
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Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California
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Contact:
- Lynn Fukushima
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female subject of age 40 years or older.
- Willing and able to provide written informed consent.
- 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.
- Forced vital capacity (FVC) percent predicted ≥ 40%.
- Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and ≤ 80.
- Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.
Exclusion Criteria:
- Interstitial lung disease other than IPF.
- Evidence of significant obstructive lung disease.
- Current diagnosis of asthma.
- Treatment with an approved or investigational antifibrotic therapy for IPF within 2 months of the Baseline bronchoscopy.
- Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and throughout the Treatment Period.
- Inability to use study inhaler device appropriately.
- Pulmonary exacerbation within 6 months prior to Screening.
- Febrile illness within 7 days prior to dosing.
- 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).
- History or evidence at screening of significant renal impairment with eGFR < 30 mL/min (region specific).
- 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).
- Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
- Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period.
- 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.
- Positive urine pregnancy test in female subjects of childbearing potential as defined below.
- Female subjects 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 last dose of study drug. Male subjects who do not agree to refrain from donating sperm during this same period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2.5 mg LTI-03 BID
2.5 mg LTI-03 BID x 14 days
|
Caveolin-1-Scaffolding-Protein-Derived Peptide
Other Names:
|
Experimental: 5 mg LTI-03 BID
5 mg LTI-03 BID x 14 days
|
Caveolin-1-Scaffolding-Protein-Derived Peptide
Other Names:
|
Placebo Comparator: Placebo
Matching placebo BID x 14 days
|
Matching placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 21 days (dosing x 14 days; follow up x 7 days)
|
Incidence of TEAEs by dose and system organ class
|
21 days (dosing x 14 days; follow up x 7 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steven A. Shoemkaer, MD, Lung Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTI-03-1002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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