A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
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ClinicalTrials.gov Identifier: NCT05954988 |
Recruitment Status :
Recruiting
First Posted : July 20, 2023
Last Update Posted : August 30, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: LTI-03 Drug: Placebo | Phase 1 |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The Sponsor, Investigator, and study personnel working on behalf of the Investigator and Sponsor will remain blinded. |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | July 6, 2023 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | January 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: 2.5 mg LTI-03 BID
2.5 mg LTI-03 BID x 14 days
|
Drug: LTI-03
Caveolin-1-Scaffolding-Protein-Derived Peptide
Other Name: Micronized dry powder in hard 2 piece hypromellose capsules |
Experimental: 5 mg LTI-03 BID
5 mg LTI-03 BID x 14 days
|
Drug: LTI-03
Caveolin-1-Scaffolding-Protein-Derived Peptide
Other Name: Micronized dry powder in hard 2 piece hypromellose capsules |
Placebo Comparator: Placebo
Matching placebo BID x 14 days
|
Drug: Placebo
Matching placebo
Other Name: Micronized lactose powder in capsule |
- 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
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05954988
Contact: Sydney Kruger, MS | 4109672905 | skruger@lungtx.com |
United States, Alabama | |
University of Alabama | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Andrea Ford | |
United States, California | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Lynn Fukushima | |
Cedars Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Emad Bayoumi | |
Germany | |
Agaplesion Evangelisches Krankenhaus Mittelhessen | Not yet recruiting |
Gießen, Germany | |
Contact: Olga Maurer | |
United Kingdom | |
University of Edinburgh | Recruiting |
Edinburgh, United Kingdom | |
Contact: Sarah McNamara | |
Royal Brompton Hospital | Recruiting |
London, United Kingdom, SW3 6HP | |
Contact: Patricia Duarte | |
Royal Victoria Infirmary | Recruiting |
Newcastle, United Kingdom | |
Contact: Ana Alvarex Franco |
Study Director: | Steven A. Shoemkaer, MD | Lung Therapeutics |
Responsible Party: | Lung Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT05954988 |
Other Study ID Numbers: |
LTI-03-1002 |
First Posted: | July 20, 2023 Key Record Dates |
Last Update Posted: | August 30, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
IPF idiopathic pulmonary fibrosis |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases |