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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LTI-03
Placebo
Sponsored by
Lung Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, idiopathic pulmonary fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of AlabamaRecruiting
  • University of Southern CaliforniaRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Agaplesion Evangelisches Krankenhaus Mittelhessen
  • University of EdinburghRecruiting
  • Royal Brompton HospitalRecruiting
  • Royal Victoria InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

2.5 mg LTI-03 BID

5 mg LTI-03 BID

Placebo

Arm Description

2.5 mg LTI-03 BID x 14 days

5 mg LTI-03 BID x 14 days

Matching placebo BID x 14 days

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs)
Incidence of TEAEs by dose and system organ class

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
August 29, 2023
Sponsor
Lung Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05954988
Brief Title
A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lung Therapeutics, Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
IPF, idiopathic pulmonary fibrosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The Sponsor, Investigator, and study personnel working on behalf of the Investigator and Sponsor will remain blinded.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2.5 mg LTI-03 BID
Arm Type
Experimental
Arm Description
2.5 mg LTI-03 BID x 14 days
Arm Title
5 mg LTI-03 BID
Arm Type
Experimental
Arm Description
5 mg LTI-03 BID x 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo BID x 14 days
Intervention Type
Drug
Intervention Name(s)
LTI-03
Other Intervention Name(s)
Micronized dry powder in hard 2 piece hypromellose capsules
Intervention Description
Caveolin-1-Scaffolding-Protein-Derived Peptide
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Micronized lactose powder in capsule
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of TEAEs by dose and system organ class
Time Frame
21 days (dosing x 14 days; follow up x 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Kruger, MS
Phone
4109672905
Email
skruger@lungtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Shoemkaer, MD
Organizational Affiliation
Lung Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Ford
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Fukushima
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Bayoumi
Facility Name
Agaplesion Evangelisches Krankenhaus Mittelhessen
City
Gießen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Maurer
Facility Name
University of Edinburgh
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah McNamara
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Duarte
Facility Name
Royal Victoria Infirmary
City
Newcastle
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Alvarex Franco

12. IPD Sharing Statement

Learn more about this trial

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

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