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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: LTI-03; Drug: Placebo

• Registration Number: NCT05954988
• Lead Sponsor: Rein Therapeutics

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.

Study Timeline

• Study First Submitted: 2022-05-20
• Study Start: 2023-07-06
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-20
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
2.5 mg LTI-03 BID	LTI-03	2.5 mg LTI-03 BID x 14 days
Placebo	Placebo	Matching placebo BID x 14 days
5 mg LTI-03 BID	LTI-03	5 mg LTI-03 BID x 14 days

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	21 days (dosing x 14 days; follow up x 7 days)	Incidence of TEAEs by dose and system organ class

Trial Locations

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