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Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

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

NCT05671835•Tvardi Therapeutics, Incorporated

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.

Exclusion Criteria

•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.

Locations (28)

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

Key Dates

Start Date

May 15, 2023

Primary Completion Date

August 14, 2025

Completion Date

August 14, 2025

Last Updated

September 30, 2025

Enrollment

100

ACTUAL participants

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

TTI-101

DRUG

Placebo

DRUG

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

NCT06238622

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

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RECRUITINGPHASE3

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

NCT07299695

Idiopathic Pulmonary FibrosisAcute Exacerbation of Idiopathic Pulmonary Fibrosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Inclusion Criteria

Exclusion Criteria

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males

Validation of the C-mo System - Cough Monitoring