The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05954988
Recruitment Status : Recruiting
First Posted : July 20, 2023
Last Update Posted : August 30, 2023
Sponsor:
Information provided by (Responsible Party):
Lung Therapeutics, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: LTI-03 Drug: Placebo Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sydney Kruger, MS 4109672905 skruger@lungtx.com

Locations
Layout table for location information
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         
Sponsors and Collaborators
Lung Therapeutics, Inc
Investigators
Layout table for investigator information
Study Director: Steven A. Shoemkaer, MD Lung Therapeutics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

Layout table for additional information
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
Keywords provided by Lung Therapeutics, Inc:
IPF
idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases