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COMPLETEDPHASE1

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

NCT05954988•Rein Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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).
+7 more criteria

Locations (7)

University of Alabama

Birmingham, Alabama, United States

University of Southern California

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Agaplesion Evangelisches Krankenhaus Mittelhessen

Giessen, Germany

University of Edinburgh

Edinburgh, United Kingdom

Royal Brompton Hospital

London, United Kingdom

Royal Victoria Infirmary

Newcastle, United Kingdom

Key Dates

Start Date

July 6, 2023

Primary Completion Date

September 25, 2024

Completion Date

September 25, 2024

Last Updated

July 31, 2025

Enrollment

ACTUAL participants

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

LTI-03

DRUG

Placebo

DRUG

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

NCT06238622

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

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RECRUITINGPHASE3

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

NCT07299695

Idiopathic Pulmonary FibrosisAcute Exacerbation of Idiopathic Pulmonary Fibrosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

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