Clinical trial NCT05671835: Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
IPF
TTI-101
Lead sponsor: Tvardi Therapeutics, Incorporated
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: 16 weeks
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of TTI-101
timeFrame: Day 1 to Week 12
measure: Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
timeFrame: Day 1 to Week 12
measure: Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
timeFrame: Day 1 to Week 12
measure: Trough Plasma Concentration (Cτ) of TTI-101
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic of University of Alabama Birmingham Hospital
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Orange
country: United States
facility: University of California Irvine (UCI) Health
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Clearwater
country: United States
facility: Saint Francis Sleep Allergy and Lung Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: UHealth - University of Miami Health Systems
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Chesterfield
country: United States
facility: The Lung Research Center
state: Missouri
city: Brooklyn
country: United States
facility: New York University Langone Pulmonary and Critical Care Associates
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Greensboro
country: United States
facility: Pulmonix
state: North Carolina
city: Winston-Salem
country: United States
facility: Salem Chest Specialists
state: North Carolina
city: Bethlehem
country: United States
facility: Saint Luke's University Hospital - Bethlehem
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Center for Advanced Heart & Lung Disease
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston (UT Health)
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
References: