Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
Purpose
The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated guidelines within 7 years prior to the date of informed consent. 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
- Unresolved respiratory tract infection within 4 weeks (including coronavirus disease 2019 [COVID-19] infections) or an acute exacerbation of IPF within 3 months prior to screening. 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TTI-101 400 mg/day |
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks. |
|
|
Experimental TTI-101 800 mg/day |
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks. |
|
|
Experimental TTI-101 1200 mg/day |
Participants will receive 1200 mg/day of TTI-101 BID for 12 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive a matching placebo BID for 12 weeks. |
|
Recruiting Locations
The Kirklin Clinic of University of Alabama Birmingham Hospital
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Saint Luke's University Hospital - Bethlehem
Bethlehem, Pennsylvania 18015
Bethlehem, Pennsylvania 18015
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
McKinney, Texas 75069
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
Baylor Scott & White Center for Advanced Heart & Lung Disease
Dallas, Texas 75226
Dallas, Texas 75226
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee 37067
Franklin, Tennessee 37067
The Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Temple University Hospital
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Salem Chest Specialists
Winston-Salem, North Carolina 27103-4007
Winston-Salem, North Carolina 27103-4007
University of Colorado School of Medicine
Aurora, Colorado 80045
Aurora, Colorado 80045
Pulmonix
Greensboro, North Carolina 27403
Greensboro, North Carolina 27403
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
New York University Langone Pulmonary and Critical Care Associates
Brooklyn, New York 11209
Brooklyn, New York 11209
The Lung Research Center
Chesterfield, Missouri 63017
Chesterfield, Missouri 63017
Minnesota Lung Center
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Tulane University School of Medicine
New Orleans, Louisiana 70112-2600
New Orleans, Louisiana 70112-2600
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Saint Francis Sleep Allergy and Lung Institute
Clearwater, Florida 33765
Clearwater, Florida 33765
MedStar Georgetown University Hospital
Georgetown, Washington 20007
Georgetown, Washington 20007
More Details
- NCT ID
- NCT05671835
- Status
- Recruiting
- Sponsor
- Tvardi Therapeutics, Incorporated