Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671835
• Other study ID #: TVD-101-003P
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Tvardi Therapeutics, Incorporated
• Contact: Russell Lesko
• Phone: Please email
• Email: info[@]tvardi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• TTI-101
Orally via a tablet.
• Placebo
Orally via a tablet.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	Saint Luke's University Hospital - Bethlehem	Bethlehem	Pennsylvania
United States	The Kirklin Clinic of University of Alabama Birmingham Hospital	Birmingham	Alabama
United States	New York University Langone Pulmonary and Critical Care Associates	Brooklyn	New York
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	The Lung Research Center	Chesterfield	Missouri
United States	Saint Francis Sleep Allergy and Lung Institute	Clearwater	Florida
United States	Baylor Scott & White Center for Advanced Heart & Lung Disease	Dallas	Texas
United States	Minnesota Lung Center	Edina	Minnesota
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee
United States	MedStar Georgetown University Hospital	Georgetown	Washington
United States	Pulmonix	Greensboro	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Metroplex Pulmonary and Sleep Center	McKinney	Texas
United States	Minnesota Lung Center	Minneapolis	Minnesota
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Pulmonary Associates PA	Phoenix	Arizona
United States	Salem Chest Specialists	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tvardi Therapeutics, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with an Adverse Event (AE)	Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs.	16 weeks
Secondary	Maximum Observed Plasma Concentration (Cmax) of TTI-101		Day 1 to Week 12
Secondary	Time of Maximum Observed Plasma Concentration (tmax) of TTI-101		Day 1 to Week 12
Secondary	Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-t]) of TTI-101		Day 1 to Week 12
Secondary	Trough Plasma Concentration (Ct) of TTI-101		Day 1 to Week 12