A new phase 2 multicenter, randomized, double-blind, placebo-controlled study (REVERT-IPF) will begin this month to evaluate the safety and tolerability of oral daily administration of TTI-101 in patients with idiopathic pulmonary fibrosis (IPF).
Participants will receive oral TTI-101 (400, 800, or 1200 mg/day) or a placebo twice daily for 12 weeks. The primary outcome measure is the number of participants with an adverse event reported within 16 weeks.
Moreover, investigators will assess TTI-101’s maximum observed plasma concentration, time of maximum observed plasma concentration, the area under the plasma concentration-time curve over a dosing interval, and trough plasma concentration.
The study, which is not yet recruiting, will enroll 100 individuals diagnosed with IPF based on either the 2018 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association International Diagnostic Guidelines or on the 2022 updated guidelines within 5 years prior to the date of informed consent. Furthermore, participants must have a chest high-resolution computed tomography scan performed within 12 months prior to providing informed consent meeting requirements for IPF diagnosis.
Participants must be 40 years old or older, have a life expectancy of at least 12 months, a predicted forced vital capacity (FVC) greater than 45%, and a ratio of forced expiratory volume in 1 second/FVC of 0.7 or higher measured pre-bronchodilator, a predicted diffusing capacity of the lungs for carbon monoxide (hemoglobin corrected) of 30% or higher, and oxygen saturation of 88% or higher with up to 2L O2/min by pulse oximetry.
Participants receiving nintedanib must have the dose stabilized for at least 3 months prior to randomization and those who had discontinued nintedanib must have a 6-week washout period before starting screening.
Excluded from the study are patients with: an unresolved respiratory tract infection within 2 weeks or an acute exacerbation of IPF within 3 months prior; a history of other types of respiratory diseases that could impact the primary protocol endpoint, the ability to do pulmonary function tests, or preclude study participation; a history or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug; clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with the participant’s ability to complete the study or logistical challenges that preclude adequate participation in the study.
Moreover, patients who show sustained improvement in the severity of IPF during the 12 months prior to screening according to the investigator’s judgment will not be considered for participation in REVERT-IPF.
Patients who are receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day of prednisolone or its equivalent within 2 weeks or pirfenidone within 3 months prior to randomization, and those with planned surgery or likely to have lung transplantation during the study, are also excluded.
The REVERT-IPF is sponsored by Tvardi Therapeutics, Inc.
Study of TTI-101 in participants with idiopathic pulmonary fibrosis. ClinicalTrials.gov. January 5, 2023. Published January 5, 2023. Accessed January 13, 2023.