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Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TTI-101
Placebo
Sponsored by
Tvardi Therapeutics, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, IPF, TTI-101

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. 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. A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) ≥30% during screening confirmed by central review. Oxygen saturation (SpO2) ≥88% with up to 2L O2/min by pulse oximetry. 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. Has a life expectancy of at least 12 months. Exclusion Criteria: 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. Planned surgery during the study. 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. 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. 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. 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. History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug. 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. Received pirfenidone within 3 months prior to randomization.

Sites / Locations

  • The Kirklin Clinic of University of Alabama Birmingham HospitalRecruiting
  • Pulmonary Associates PARecruiting
  • University of Colorado School of MedicineRecruiting
  • Saint Francis Sleep Allergy and Lung InstituteRecruiting
  • Tulane University School of MedicineRecruiting
  • Minnesota Lung CenterRecruiting
  • The Lung Research CenterRecruiting
  • Somnos Clinical ResearchRecruiting
  • New York University Langone Pulmonary and Critical Care AssociatesRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • PulmonixRecruiting
  • Salem Chest SpecialistsRecruiting
  • Temple University HospitalRecruiting
  • Clinical Trials Center of Middle TennesseeRecruiting
  • Metroplex Pulmonary and Sleep CenterRecruiting
  • Inova Fairfax Medical CampusRecruiting
  • MedStar Georgetown University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

TTI-101 400 mg/day

TTI-101 800 mg/day

TTI-101 1200 mg/day

Placebo

Arm Description

Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.

Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.

Participants will receive 1200 mg/day of TTI-101 BID for 12 weeks.

Participants will receive a matching placebo BID for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of TTI-101
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Trough Plasma Concentration (Cτ) of TTI-101

Full Information

First Posted
January 3, 2023
Last Updated
October 19, 2023
Sponsor
Tvardi Therapeutics, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05671835
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tvardi Therapeutics, Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic Pulmonary Fibrosis, IPF, TTI-101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TTI-101 400 mg/day
Arm Type
Experimental
Arm Description
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
Arm Title
TTI-101 800 mg/day
Arm Type
Experimental
Arm Description
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.
Arm Title
TTI-101 1200 mg/day
Arm Type
Experimental
Arm Description
Participants will receive 1200 mg/day of TTI-101 BID for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a matching placebo BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TTI-101
Intervention Description
Orally via a tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally via a tablet.
Primary Outcome Measure Information:
Title
Number of Participants with an Adverse Event (AE)
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of TTI-101
Time Frame
Day 1 to Week 12
Title
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
Time Frame
Day 1 to Week 12
Title
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Time Frame
Day 1 to Week 12
Title
Trough Plasma Concentration (Cτ) of TTI-101
Time Frame
Day 1 to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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. A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) ≥30% during screening confirmed by central review. Oxygen saturation (SpO2) ≥88% with up to 2L O2/min by pulse oximetry. 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. Has a life expectancy of at least 12 months. Exclusion Criteria: 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. Planned surgery during the study. 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. 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. 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. 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. History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug. 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. Received pirfenidone within 3 months prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Russell Lesko
Phone
Please email
Email
info@tvardi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kari Anne Rowland, MS
Phone
Please email
Email
info@tvardi.com
Facility Information:
Facility Name
The Kirklin Clinic of University of Alabama Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tejaswaini Kulkarni, M.D.
Phone
205-934-6109
Email
tkulkarni@uabmc.edu
Facility Name
Pulmonary Associates PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kellie Barbour
Phone
602-257-4252
Email
k.barbour@pulmnaryassociates.com
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haylie Lengel
Phone
970-376-8303
Email
Haylie.Lengel@cuanschutz.edu
Facility Name
Saint Francis Sleep Allergy and Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2600
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan MacKinnon
Phone
952-852-5342
Email
sue.mackinnon@mlcmsi.com
Facility Name
The Lung Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Shipp, RRT
Phone
314-682-3653
Email
Anna.shipp@stlukes-stl.com
Facility Name
Somnos Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Bradford
Phone
402-770-7403
Email
wendy@somnos.com
Facility Name
New York University Langone Pulmonary and Critical Care Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Padilla, M.D.
Phone
212-241-5656
Email
Maria.padilla@mssm.edu
Facility Name
Pulmonix
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murali Ramaswamy
Phone
336-522-8870
Email
Murali.ramaswamy@pulmonix.com
Facility Name
Salem Chest Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen McCutcheon
Phone
336-659-8414
Email
kmccutcheon@southeasternresearchcenter.com
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Cirillo
Phone
929-455-5970
Email
julia.cirillo@nyulangone.org
Facility Name
Clinical Trials Center of Middle Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Robbs
Phone
615-205-8352
Email
lrobbs@ctcmidtn.com
Facility Name
Metroplex Pulmonary and Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahrukh A, Kureishy
Phone
972-954-6002
Email
Shahrukh_kureishy@yahoo.com
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Good
Phone
703-776-5444
Email
Christina.Good@inova.org
Facility Name
MedStar Georgetown University Hospital
City
Georgetown
State/Province
Washington
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

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