LTI-03 for Idiopathic pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- 1. Male or female age 40 years or older."}
• {"criterion_text":"- 2. Willing and able to provide written informed consent."}
• {"criterion_text":"- 3. Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT lung fibrosis by central read during screening must involve ≥ 10% of the lung and be greater than emphysema involvement of the lung."}
• {"criterion_text":"- 4. Forced vital capacity (FVC) percent predicted ≥ 45 at Screening."}
• {"criterion_text":"- 5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization."}
• {"criterion_text":"- 6. Participants receiving nintedanib, pirfenidone, or nerandomilast (where approved for marketing) for IPF treatment must have been on a stable prescribed dose for at least 12 weeks prior to Randomization."}
• {"criterion_text":"- 7. Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization."}
• {"criterion_text":"- 8. Able to adequately self-administer study drug using the protocol-specified inhaler device."}

Exclusion criteria

• {"criterion_text":"- 1. Forced expiratory volume in 1 second (FEV1)/FVC < 0.7 at Screening."}
• {"criterion_text":"- 10. Active or history of malignancies within 5 years prior to Randomization, with the exception of localized nonmetastatic basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer."}
• {"criterion_text":"- 11. Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol; or an expected survival of less than 24 weeks."}
• {"criterion_text":"- 12. Positive pregnancy test in female participants of childbearing potential (defined below)."}
• {"criterion_text":"- 13. Female participants who are lactating."}
• {"criterion_text":"- 14. 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 participants who do not agree to refrain from donating sperm during this same period."}
• {"criterion_text":"- These methods of contraception are acceptable: − Bilateral tubal ligation; male sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; and copper intrauterine devices. − True abstinence when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception − Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner must be documented as the sole partner Contraceptive requirements do not apply for participants who are exclusively in same sex relationships. If a participant who is in a same sex relationship at the time of signing the ICF becomes engaged in a heterosexual relationship, they must agree to use contraception as described and as outlined in the protocol and ICF. NOTE: Female participants who are surgically sterile or post-menopausal for at least 12 months without any other underlying medical cause are not considered to be of childbearing potential."}
• {"criterion_text":"- 2. Use of N-acetyl cysteine or other supplements including but not limited to quercetin, omega-3 fatty acids, dehydroepiandrosterone, polyphenols, and phytochemicals within 7 days prior to Randomization and through Week 24."}
• {"criterion_text":"- 3. Use of systemic corticosteroids at doses > 10 mg/day of prednisone or equivalent within 28 days prior to Randomization."}
• {"criterion_text":"- 4. Active smoker."}
• {"criterion_text":"- 5. Pulmonary exacerbation within 3 months prior to Screening."}
• {"criterion_text":"- 6. Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization."}
• {"criterion_text":"- 7. Participation in a clinical study or treatment with an investigational drug or device within 28 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer)."}
• {"criterion_text":"- 8. History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2."}
• {"criterion_text":"- 9. 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 while not on anticoagulant medication."}

Primary endpoints

• {"endpoint_text":"- The incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24.","definition_or_measurement_approach":"Incidence (number and frequency) of TEAEs collected and reported from Day 1 through Week 24."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline through 24 weeks in forced vital capacity (FVC) in mL.","definition_or_measurement_approach":"Change from baseline to Week 24 in FVC measured in mL."}
• {"endpoint_text":"- Change from baseline through 24 weeks in percent predicted forced vital capacity (ppFVC).","definition_or_measurement_approach":"Change from baseline to Week 24 in percent predicted FVC (ppFVC)."}
• {"endpoint_text":"- Change from baseline at 24 weeks in lung fibrosis measured by high resolution computed tomography (HRCT).","definition_or_measurement_approach":"Change from baseline to Week 24 in extent of lung fibrosis as assessed by HRCT (central read)."}
• {"endpoint_text":"- Exploratory Endpoint: Change from baseline through 24 weeks in the Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnea and cough domains.","definition_or_measurement_approach":"Change from baseline to Week 24 in L-PF questionnaire scores for dyspnea and cough domains (patient-reported outcome)."}
• {"endpoint_text":"- Exploratory Endpoint: Time to all-cause respiratory hospitalization lung transplantation, or death through 28 weeks.","definition_or_measurement_approach":"Time-to-event analysis for time to first occurrence of respiratory hospitalization, lung transplantation, or death through Week 28."}
• {"endpoint_text":"- Exploratory Endpoint: Change from baseline through 24 weeks for biomarkers related to the pathophysiology of IPF.","definition_or_measurement_approach":"Change from baseline to Week 24 in predefined pharmacodynamic biomarkers associated with IPF pathophysiology."}

Other endpoints

• {"endpoint_text":"- Exploratory Endpoint: Change from baseline through 24 weeks in the Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnea and cough domains.","definition_or_measurement_approach":"Patient-reported outcomes: change from baseline to Week 24 in L-PF dyspnea and cough domain scores."}
• {"endpoint_text":"- Exploratory Endpoint: Time to all-cause respiratory hospitalization lung transplantation, or death through 28 weeks.","definition_or_measurement_approach":"Time-to-event endpoint measured through Week 28 (time to respiratory hospitalization, lung transplant, or death)."}
• {"endpoint_text":"- Exploratory Endpoint: Change from baseline through 24 weeks for biomarkers related to the pathophysiology of IPF.","definition_or_measurement_approach":"Change from baseline to Week 24 in predefined PD biomarkers related to IPF."}

Methods

• Online advertisements (banners and posts) — materials listed for both Germany and Poland (Online Banners, Online Posts, Online Advertisement Banners, Online Advertisement Posts).
• Doctor-to-patient letters (Dr-to-Patient Letter) — site-mediated recruitment material.
• Patient brochures (digital and paper) and pre-enrollment information cards — Patient Brochure, Patient Brochure_Digital, Pre-Enrollment Information Card, Patient Pre-Enrollment Information Card.
• Site-based outreach via recruitment arrangements and addenda to recruitment/informed consent procedures (country-specific K1/K2 documents for Germany and Poland).

Germany

Earliest CTIS Part Ii Submission Date

07-07-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

259

Number Of Sites

4

Number Of Participants

16

Poland

Earliest CTIS Part Ii Submission Date

25-09-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

179

Number Of Sites

4

Number Of Participants

12

Primary sponsor

Full Name

Rein Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

Full CRO service: Clinical Monitoring, Medical Monitoring, Biostatistics, Feasibility and Site ID, Study Startup, Site Contracts, Site Payments, Medical Writing, Investigator Meeting, Document Control, Data Management

Name

4g Clinical LLC

Responsibilities

Randomization, IXRS

Third parties

• {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"Database build","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Qureight Limited","duties_or_roles":"Imaging analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Provide spirometry machine to sites","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Randomization, IXRS","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central Laboratory, Testing/analysis of samples, EU sample management (collection/shipping) - PPD GCL will ship biomarker samples at the end of study to Bioagilytix Labs","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"IQL will ship biomarker samples at the end of study to BioAgilytix Labs","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"COA licensing and translations for paper questionnaire (LPF Symptoms and LPF Impacts)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Full CRO service: Clinical Monitoring, Medical Monitoring, Biostatistics, Feasibility and Site ID, Study Startup, Site Contracts, Site Payments, Medical Writing, Investigator Meeting, Document Control, Data Management","organisation_type":"Pharmaceutical company"}