REVERT Idiopathic Pulmonary Fibrosis Clinical Trial
Tvardi Clinical Trials
TTI-101 in Idiopathic Pulmonary Fibrosis
REVERT IPF or Idiopathic Pulmonary Fibrosis Clinical Trial
Clinical Trial Title: 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 (TVD-101-003P)
ClinicalTrials.gov (NCT05671835) Clinical Trial Title: Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
The REVERT IPF Phase 2 clinical trial is testing whether an investigational drug called TTI-101 is safe, well tolerated, and effective as an oral medication in adults with idiopathic pulmonary fibrosis (IPF) as an antifibrotic therapy or treatment. The study will test 3 different doses of TTI-101 compared to placebo (a pill that contains no medicine).
TTI-101 comes in tablet form and is taken twice daily with a glass of water after a meal.
FDA Grants Orphan Drug Designation to TTI-101 for IPF
In 2022 the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to TTI-101 as a drug that shows promise in treating IPF. This designation helps to expedite clinical development of TTI-101.
What is Idiopathic Pulmonary Fibrosis or IPF?
Idiopathic pulmonary fibrosis or IPF is a condition where fibrosis accumulates in the lungs causing difficulty breathing.
Who May be Eligible to Participate in the Clinical Trial?
If you are an adult 40 years old or older diagnosed with idiopathic pulmonary (lung) fibrosis (IPF) either taking nintedanib (OFEV) or unable to take nintedanib (OFEV) or pirfenidone (Esbriet), you may be eligible to participate in our clinical trial. Please contact your preferred active clinical trial location.
What Can you Expect if You Participate in the Clinical Trial?
- Your participation in this clinical trial will include 3 periods: screening, clinical trial treatment, and follow-up. During the screening period, your doctor will perform tests to find out if you are eligible to take the clinical trial treatment given during REVERT. If you are eligible, you will be assigned either the study treatment or placebo (a tablet that looks like TTI-101 but contains no active medication), and you will receive treatment for 12 weeks. Four weeks after the last dose, you will be asked to return for a follow-up visit.
- The duration of the clinical trial is up to 20 weeks. This participation includes:
- Screening: up to 4 weeks
- Core Period: 12 weeks
- Extension Period: 4 weeks after last dose of either TTI-101 or placebo.
- Participants will attend visits every 2-4 weeks for physical examination and treatment dispensing.
- Examinations and assessments required for clinical trial not covered by insurance will be provided at no cost to you. Participants may be reimbursed for eligible costs associated with the clinical trial.
TTI-101 is an oral medication (taken by mouth) and is a small molecule, direct inhibitor of STAT3. STAT3 is a key regulatory protein which plays a critical role in the development of fibrosis that causes difficulty breathing in patients suffering with IPF. TTI-101 has completed a first-in-man Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. To date, TTI-101 monotherapy has been well-tolerated and has clinical activity.
Clinical Trial Locations
Interested in participating at one of our active sites at multiple U.S. locations or would you like to find out more information about our participating locations across the U.S.? Learn more about the inclusion and exclusion criteria, clinical trial objectives, and participating sites by clicking the link below.
About Tvardi Therapeutics
The REVERT IPF study is sponsored by Tvardi Therapeutics, a privately held, clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3 which plays a central role in the pathogenesis of many inflammatory and fibrotic diseases. Tvardi Therapeutics is studying new and more effective ways to treat idiopathic pulmonary fibrosis.