RENEW - A Phase 2 Study of the Safety, Tolerability and Efficacy of LTI-03 in Patients with Idiopathic Pulmonary Fibrosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rein Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

22 Apr 2026 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Rein Therapeutics, Inc

External identifiers

EU CT number

2025-520715-13-00

ClinicalTrials.gov

NCT06968845

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

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.

Secondary objectives 2

1. To determine the efficacy of inhaled LTI-03 in participants diagnosed with IPF within 5 years of Screening who may be receiving SoC antifibrotic therapy.
2. Exploratory Objectives: In participants diagnosed with IPF within 5 years of Screening who may be receiving SoC antifibrotic therapy: • To assess the effect of inhaled LTI-03 on patient-reported outcomes (PROs). • To assess the effect of inhaled LTI-03 on the occurrence of respiratory hospitalizations. • To evaluate the pharmacodynamic (PD) biomarkers of inhaled LTI-03.

Conditions and MedDRA coding

Idiopathic Pulmonary Fibrosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Male or female age 40 years or older.
2. 2. Willing and able to provide written informed consent.
3. 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. 4. Forced vital capacity (FVC) percent predicted ≥ 45 at Screening.
5. 5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
6. 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. 7. Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization.
8. 8. Able to adequately self-administer study drug using the protocol-specified inhaler device.

Exclusion criteria 15

1. 1. Forced expiratory volume in 1 second (FEV1)/FVC < 0.7 at Screening.
2. 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. 3. Use of systemic corticosteroids at doses > 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
4. 4. Active smoker.
5. 5. Pulmonary exacerbation within 3 months prior to Screening.
6. 6. Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.
7. 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. 8. History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
9. 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.
10. 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. 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. 12. Positive pregnancy test in female participants of childbearing potential (defined below).
13. 13. Female participants who are lactating.
14. 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.
15. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24.

Secondary endpoints 6

1. Change from baseline through 24 weeks in forced vital capacity (FVC) in mL.
2. Change from baseline through 24 weeks in percent predicted forced vital capacity (ppFVC).
3. Change from baseline at 24 weeks in lung fibrosis measured by high resolution computed tomography (HRCT).
4. Exploratory Endpoint: Change from baseline through 24 weeks in the Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnea and cough domains.
5. Exploratory Endpoint: Time to all-cause respiratory hospitalization lung transplantation, or death through 28 weeks.
6. Exploratory Endpoint: Change from baseline through 24 weeks for biomarkers related to the pathophysiology of IPF.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rein Therapeutics Inc.

Sponsor organisation

Rein Therapeutics Inc.

Address

12407 North Mopac Expressway Suite 250 # 390

City

Austin

Postcode

78758-2491

Country

United States

Scientific contact point

Organisation

Rein Therapeutics Inc.

Contact name

Information Desk

Public contact point

Organisation

Rein Therapeutics Inc.

Contact name

Information Desk

Third parties 8

Locations

2 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications