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Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05671835
Recruitment Status : Recruiting
First Posted : January 5, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
Tvardi Therapeutics, Incorporated

Study Description
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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).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: TTI-101 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TTI-101 400 mg/day
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
 Drug: TTI-101
Orally via a tablet.
Experimental: TTI-101 800 mg/day
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.
 Drug: TTI-101
Orally via a tablet.
Experimental: TTI-101 1200 mg/day
Participants will receive 1200 mg/day of TTI-101 BID for 12 weeks.
 Drug: TTI-101
Orally via a tablet.
Placebo Comparator: Placebo
Participants will receive a matching placebo BID for 12 weeks.
 Drug: Placebo
Orally via a tablet.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with an Adverse Event (AE) [ Time Frame: 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of TTI-101 [ Time Frame: Day 1 to Week 12 ]
  2. Time of Maximum Observed Plasma Concentration (tmax) of TTI-101 [ Time Frame: Day 1 to Week 12 ]
  3. Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101 [ Time Frame: Day 1 to Week 12 ]
  4. Trough Plasma Concentration (Cτ) of TTI-101 [ Time Frame: Day 1 to Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 5 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 ATS/ERS/JRS/ALAT guidelines and confirmed by central review.
  3. Greater than 45% 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) ≥30% during screening confirmed by central review.
  5. Oxygen saturation (SpO2) ≥88% with up to 2L O2/min by pulse oximetry.
  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 2 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05671835


Contacts
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Contact: Russell Lesko Please email info@tvardi.com
Contact: Kari Anne Rowland, MS Please email info@tvardi.com

Locations
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United States, Alabama
The Kirklin Clinic of University of Alabama Birmingham Hospital Recruiting
Birmingham, Alabama, United States, 35233
Contact: Tejaswaini Kulkarni, M.D.    205-934-6109    tkulkarni@uabmc.edu   
United States, Arizona
Pulmonary Associates PA Recruiting
Phoenix, Arizona, United States, 85006
Contact: Kellie Barbour    602-257-4252    k.barbour@pulmnaryassociates.com   
United States, Colorado
University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Haylie Lengel    970-376-8303    Haylie.Lengel@cuanschutz.edu   
United States, Florida
Saint Francis Sleep Allergy and Lung Institute Recruiting
Clearwater, Florida, United States, 33765
United States, Minnesota
Minnesota Lung Center Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Susan MacKinnon    952-852-5342    sue.mackinnon@mlcmsi.com   
United States, Missouri
The Lung Research Center Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Anna Shipp, RRT    314-682-3653    Anna.shipp@stlukes-stl.com   
United States, Nebraska
Somnos Clinical Research Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Wendy Bradford    402-770-7403    wendy@somnos.com   
United States, New York
New York University Langone Pulmonary and Critical Care Associates Recruiting
Brooklyn, New York, United States, 11209
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Maria Padilla, M.D.    212-241-5656    Maria.padilla@mssm.edu   
United States, North Carolina
Pulmonix Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Murali Ramaswamy    336-522-8870    Murali.ramaswamy@pulmonix.com   
Salem Chest Specialists Recruiting
Winston-Salem, North Carolina, United States, 27103-4007
Contact: Karen McCutcheon    336-659-8414    kmccutcheon@southeasternresearchcenter.com   
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Julia Cirillo    929-455-5970    julia.cirillo@nyulangone.org   
United States, Tennessee
Clinical Trials Center of Middle Tennessee Recruiting
Franklin, Tennessee, United States, 37067
Contact: Lindsey Robbs    615-205-8352    lrobbs@ctcmidtn.com   
United States, Texas
Metroplex Pulmonary and Sleep Center Recruiting
McKinney, Texas, United States, 75069
Contact: Shahrukh A, Kureishy    972-954-6002    Shahrukh_kureishy@yahoo.com   
United States, Virginia
Inova Fairfax Medical Campus Recruiting
Falls Church, Virginia, United States, 22042
Contact: Christina Good    703-776-5444    Christina.Good@inova.org   
Sponsors and Collaborators
Tvardi Therapeutics, Incorporated
More Information
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Responsible Party: Tvardi Therapeutics, Incorporated
ClinicalTrials.gov Identifier: NCT05671835    
Other Study ID Numbers: TVD-101-003P
First Posted: January 5, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tvardi Therapeutics, Incorporated:
Idiopathic Pulmonary Fibrosis
IPF
TTI-101
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases