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

Last updated: April 21, 2025
Sponsor: Rein Therapeutics
Overall Status: Completed

Phase

1

Condition

Idiopathic Pulmonary Fibrosis

Cystic Fibrosis

Pulmonary Fibrosis

Treatment

LTI-03

Placebo

Clinical Study ID

NCT05954988
LTI-03-1002
  • Ages > 40
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 lungbiopsy 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 ≥ 30and ≤ 80.

  6. Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.

Exclusion

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 2months of the Baseline bronchoscopy.

  5. Use of N-acetyl cysteine or other supplements within 7 days prior to dosing andthroughout 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 ordevice within 30 days of the Screening Visit (or 5 half-lives of the investigationalagent, whichever is longer).

  10. History or evidence at screening of significant renal impairment with eGFR < 30mL/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 secor INR > 2.3 (region specific).

  12. Serious or active medical or psychiatric condition which, in the opinion of theInvestigator, may interfere with treatment, assessment, or compliance with theprotocol.

  13. Vaccination within 2 weeks of start of dosing (Day 1) and throughout the TreatmentPeriod.

  14. Subject has severe progressive or uncontrolled, clinically significant disease thatin the judgment of the investigator or designee renders the subject unsuitable forthe study.

  15. Positive urine pregnancy test in female subjects of childbearing potential asdefined below.

  16. Female subjects who are lactating.

  17. Females of childbearing potential (FOCBP) and men with partners of childbearingpotential who do not agree to use an acceptable form of contraception for theduration of study treatment and for at least 90 days after the last dose of studydrug. Male subjects who do not agree to refrain from donating sperm during this sameperiod.

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: LTI-03
Phase: 1
Study Start date:
July 06, 2023
Estimated Completion Date:
September 25, 2024

Study 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.

Connect with a study center

  • Agaplesion Evangelisches Krankenhaus Mittelhessen

    Gießen,
    Germany

    Site Not Available

  • University of Edinburgh

    Edinburgh,
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London, SW3 6HP
    United Kingdom

    Site Not Available

  • Study Site

    London, SW3 6HP
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle,
    United Kingdom

    Site Not Available

  • University of Alabama

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.