COMPLETED

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Conditions

Idiopathic Pulmonary Fibrosis IPF TTI-101

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

REVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Quick Facts

Study Start:2023-05-15

Study Completion:2025-08-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05671835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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.	1. 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.

Inclusion Criteria

Exclusion Criteria

1. 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.

1. 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.

Contacts and Locations

Study Locations (Sites)

The Kirklin Clinic of University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233

United States

University of California San Diego

La Jolla, California, 92037

United States

University of California Irvine (UCI) Health

Orange, California, 92868

United States

University of Colorado School of Medicine

Aurora, Colorado, 80045

United States

Saint Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765

United States

University of Florida

Gainesville, Florida, 32610

United States

UHealth - University of Miami Health Systems

Miami, Florida, 33125

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Chicago Medicine

Chicago, Illinois, 60637

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

United States

Tulane University School of Medicine

New Orleans, Louisiana, 70112-2600

United States

The Lung Research Center

Chesterfield, Missouri, 63017

United States

New York University Langone Pulmonary and Critical Care Associates

Brooklyn, New York, 10017

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Pulmonix

Greensboro, North Carolina, 27403

United States

Salem Chest Specialists

Winston-Salem, North Carolina, 27103-4007

United States

Saint Luke's University Hospital - Bethlehem

Bethlehem, Pennsylvania, 18020

United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

The Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067

United States

Baylor Scott & White Center for Advanced Heart & Lung Disease

Dallas, Texas, 75246

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

University of Texas Health Science Center at Houston (UT Health)

Houston, Texas, 77030

United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069

United States

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: Tvardi Therapeutics, Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-15

Study Completion Date2025-08-14

Study Record Updates

Study Start Date2023-05-15

Study Completion Date2025-08-14

Terms related to this study

Keywords Provided by Researchers

Idiopathic Pulmonary Fibrosis
IPF
TTI-101

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis