Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
NCT ID: NCT05671835
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2023-05-15
2025-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TTI-101 400 mg/day
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
TTI-101
Orally via a tablet.
TTI-101 800 mg/day
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.
TTI-101
Orally via a tablet.
Placebo
Participants will receive a matching placebo BID for 12 weeks.
Placebo
Orally via a tablet.
Interventions
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TTI-101
Orally via a tablet.
Placebo
Orally via a tablet.
Eligibility Criteria
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Inclusion Criteria
2. Chest high-resolution computed tomography scan (HRCT) performed within 12 months prior to providing informed consent meeting requirements for IPF diagnosis based on 2018 or 2022 ATS/ERS/JRS/ALAT guidelines and confirmed by central review.
3. Greater than 40% of predicted forced vital capacity (FVC) and a ratio of forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 measured pre-bronchodilator during screening confirmed by central review.
4. A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin \[Hb\] corrected) ≥25% during screening confirmed by central review.
5. Oxygen saturation (SpO2) ≥88% with up to 4L O2/min by pulse oximetry at rest.
6. If currently receiving nintedanib, dose must have been stable for ≥3 months prior to randomization. If participant has previously discontinued nintedanib, there is a 6-week washout period required before screening can begin.
7. Has a life expectancy of at least 12 months.
Exclusion Criteria
2. Planned surgery during the study.
3. The investigator judges that there has been sustained improvement in the severity of IPF during the 12 months prior to screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest.
4. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the investigator, would impact the primary protocol endpoint or ability to do pulmonary function tests (PFTs), or otherwise preclude participation in the study.
5. Likely to have lung transplantation during the study. Note: Participant may be on a lung transplant list if the investigator anticipates the participant will be able to complete the study prior to transplant.
6. Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with the participant's ability to complete this study according to the investigator's judgment, or logistical challenges that, in the opinion of the investigator, preclude adequate participation in the study.
7. History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug.
8. Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day of prednisolone or its equivalent within 2 weeks prior to randomization.
9. Received pirfenidone within 3 months prior to randomization.
10. Smoking or vaping of any kind within 3 months of screening.
40 Years
ALL
No
Sponsors
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Tvardi Therapeutics, Incorporated
INDUSTRY
Responsible Party
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Locations
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The Kirklin Clinic of University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
University of California San Diego
La Jolla, California, United States
University of California Irvine (UCI) Health
Orange, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Saint Francis Sleep Allergy and Lung Institute
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
UHealth - University of Miami Health Systems
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
The Lung Research Center
Chesterfield, Missouri, United States
New York University Langone Pulmonary and Critical Care Associates
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Pulmonix
Greensboro, North Carolina, United States
Salem Chest Specialists
Winston-Salem, North Carolina, United States
Saint Luke's University Hospital - Bethlehem
Bethlehem, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
Baylor Scott & White Center for Advanced Heart & Lung Disease
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at Houston (UT Health)
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Countries
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Other Identifiers
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TVD-101-003P
Identifier Type: -
Identifier Source: org_study_id
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