A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Rein Therapeutics
Study ID
NCT06968845
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LTI-03 — DRUG
    Caveolin-1-Scaffolding-Protein-Derived Peptide
  • Dry Powder Inhaler — DEVICE
    Plastiape Monodose RS01 Model 7
  • Placebo — DRUG
    Lactose powder

Study Details

Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring. The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate. Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period. Study Assessments: Up to 9 visits to the study clinic will be required. Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler. Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only. Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis. Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.

Key Dates

Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: (1) 2.5 mg LTI-03 capsule BID
    Caveolin-1-Scaffolding-Protein-Derived Peptide
  • Experimental: (2) 2.5 mg LTI-03 capsules BID
    Caveolin-1-Scaffolding-Protein-Derived Peptide
  • Placebo Comparator: (1) Placebo capsule BID
    Lactose powder
  • Placebo Comparator: (2) Placebo capsules BID
    Lactose powder

Primary Outcome Measure

Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 through Week 24 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
UAB Lung Health CenterBirminghamAlabama35233
Tejaswini Kulkarni, MD (PRINCIPAL_INVESTIGATOR)
Paradigm Clinical Research Centers, LLCSan DiegoCalifornia92108
Cheryl Bolovits
[email protected]
Daniel Jones, MD (PRINCIPAL_INVESTIGATOR)
National Jewish HealthDenverColorado80206
Evans Fernandez Perez, MD (PRINCIPAL_INVESTIGATOR)
Yale University School of MedicineNew HavenConnecticut06511
Maksym Minasyan
[email protected]
Danielle Antin-Ozerkis, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FloridaWestonFlorida33331
Osvaldo Perez
[email protected]
David Zisman, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HealthDetroitMichigan48202
Deepti Naidu
[email protected]
Asif M. Abdul Hameed, MD (PRINCIPAL_INVESTIGATOR)
The Lung Research Center, LLCChesterfieldMissouri63017
Neil Ettinger, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityMissouri66160
Mark Hamblin, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Adam Souter
Jason Lobo, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Timothy Whelan, MD (PRINCIPAL_INVESTIGATOR)
El Paso Pulmonary AssociationEl PasoTexas79902
Karina Espino
[email protected]
Carlo M. Hatem, MD (PRINCIPAL_INVESTIGATOR)

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