Phase
Condition
Idiopathic Pulmonary Fibrosis
Lung Injury
Lung Disease
Treatment
Placebo
TTI-101
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ LatinAmerican Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated guidelines within 7 years prior to the date of informed consent.
Chest high-resolution computed tomography scan (HRCT) performed within 12 monthsprior to providing informed consent meeting requirements for IPF diagnosis based on 2018 or 2022 ATS/ERS/JRS/ALAT guidelines and confirmed by central review.
Greater than 40% of predicted forced vital capacity (FVC) and a ratio of forcedexpiratory volume in 1 second (FEV1)/FVC ≥0.7 measured pre-bronchodilator duringscreening confirmed by central review.
A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) ≥25% during screening confirmed by central review.
Oxygen saturation (SpO2) ≥88% with up to 4L O2/min by pulse oximetry at rest.
If currently receiving nintedanib, dose must have been stable for ≥3 months prior torandomization. If participant has previously discontinued nintedanib, there is a 6-week washout period required before screening can begin.
Has a life expectancy of at least 12 months.
Exclusion
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 toscreening.
Planned surgery during the study.
The investigator judges that there has been sustained improvement in the severity ofIPF during the 12 months prior to screening, based on changes in FVC, DLCO, and/orHRCT scans of the chest.
History of other types of respiratory diseases including diseases or disorders ofthe airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wallthat, in the opinion of the investigator, would impact the primary protocol endpointor ability to do pulmonary function tests (PFTs), or otherwise precludeparticipation in the study.
Likely to have lung transplantation during the study. Note: Participant may be on alung transplant list if the investigator anticipates the participant will be able tocomplete the study prior to transplant.
Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal,endocrine, metabolic, neurologic, or psychiatric disorders that may interfere withthe participant's ability to complete this study according to the investigator'sjudgment, or logistical challenges that, in the opinion of the investigator,preclude adequate participation in the study.
History or difficulty of swallowing, malabsorption, or other chronicgastrointestinal disease or conditions that may hamper compliance and/or absorptionof the study drug.
Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day ofprednisolone or its equivalent within 2 weeks prior to randomization.
Received pirfenidone within 3 months prior to randomization.
Smoking or vaping of any kind within 3 months of screening.
Study Design
Connect with a study center
The Kirklin Clinic of University of Alabama Birmingham Hospital
Birmingham, Alabama 35233
United StatesSite Not Available
Pulmonary Associates PA
Phoenix, Arizona 85006
United StatesSite Not Available
University of California San Diego
La Jolla, California 92037
United StatesSite Not Available
University of California Irvine (UCI) Health
Orange, California 92868
United StatesSite Not Available
University of California San Diego
San Diego, California 92037
United StatesSite Not Available
University of Colorado School of Medicine
Aurora, Colorado 80045
United StatesSite Not Available
MedStar Georgetown University Hospital
Georgetown, District of Columbia 20007
United StatesSite Not Available
Saint Francis Sleep Allergy and Lung Institute
Clearwater, Florida 33765
United StatesSite Not Available
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
UHealth - University of Miami Health Systems
Miami, Florida 33125
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago Medicine
Chicago, Illinois 60637
United StatesSite Not Available
Northwestern University
Evanston, Illinois 60208
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Tulane University School of Medicine
New Orleans, Louisiana 70112-2600
United StatesSite Not Available
Minnesota Lung Center
Edina, Minnesota 55435
United StatesSite Not Available
Minnesota Lung Center
Minneapolis, Minnesota 55407
United StatesSite Not Available
The Lung Research Center
Chesterfield, Missouri 63017
United StatesSite Not Available
Somnos Clinical Research
Lincoln, Nebraska 68506
United StatesSite Not Available
New York University Langone Pulmonary and Critical Care Associates
Brooklyn, New York 10017
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Pulmonix
Greensboro, North Carolina 27403
United StatesSite Not Available
Salem Chest Specialists
Winston-Salem, North Carolina 27103-4007
United StatesSite Not Available
Saint Luke's University Hospital - Bethlehem
Bethlehem, Pennsylvania 18020
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
The Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee 37067
United StatesSite Not Available
Baylor Scott & White Center for Advanced Heart & Lung Disease
Dallas, Texas 75246
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health Science Center at Houston (UT Health)
Houston, Texas 77030
United StatesSite Not Available
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available
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