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RENEW - A Phase 2 Study of the Safety, Tolerability and Efficacy of LTI-03 in Patients with Idiopathic Pulmonary Fibrosis
EU CTIS ID: 2025-520715-13-00
What this study is testing
To determine the safety and tolerability of inhaled LTI-03 in participants diagnosed with IPF within 5 years of Screening who may be receiving SoC antifibrotic therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female age 40 years or older.
- 2. Willing and able to provide written informed consent.
- 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.
- 4. Forced vital capacity (FVC) percent predicted ≥ 45 at Screening.
- 5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
- 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.
You likely can't join if
- 1. Forced expiratory volume in 1 second (FEV1)/FVC < 0.7 at Screening.
- 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.
- 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.
- 12. Positive pregnancy test in female participants of childbearing potential (defined below).
- 13. Female participants who are lactating.
- 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.
See the full eligibility criteria
Who can join
- 1. Male or female age 40 years or older.
- 2. Willing and able to provide written informed consent.
- 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.
- 4. Forced vital capacity (FVC) percent predicted ≥ 45 at Screening.
- 5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
- 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.
- 7. Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization.
- 8. Able to adequately self-administer study drug using the protocol-specified inhaler device.
What rules you out
- 1. Forced expiratory volume in 1 second (FEV1)/FVC < 0.7 at Screening.
- 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.
- 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.
- 12. Positive pregnancy test in female participants of childbearing potential (defined below).
- 13. Female participants who are lactating.
- 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.
- 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.
- 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.
- 3. Use of systemic corticosteroids at doses > 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
- 4. Active smoker.
- 5. Pulmonary exacerbation within 3 months prior to Screening.
- 6. Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.
- 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).
- 8. History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.