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Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05671835
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tvardi Therapeutics, Incorporated
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: TTI-101 400 mg/day

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

Experimental: TTI-101 800 mg/day

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

Experimental: TTI-101 1200 mg/day

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

Placebo Comparator: Placebo

Participants will receive a matching placebo BID for 12 weeks.

Interventions

Drug: - TTI-101

Orally via a tablet.

Drug: - Placebo

Orally via a tablet.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

The Kirklin Clinic of University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233

Site Contact

Tejaswaini Kulkarni, M.D.

tkulkarni@uabmc.edu

205-934-6109

Pulmonary Associates PA, Phoenix, Arizona

Status

Active, not recruiting

Address

Pulmonary Associates PA

Phoenix, Arizona, 85006

Aurora, Colorado

Status

Recruiting

Address

University of Colorado School of Medicine

Aurora, Colorado, 80045

Site Contact

Haylie Lengel

Haylie.Lengel@cuanschutz.edu

970-376-8303

Clearwater, Florida

Status

Recruiting

Address

Saint Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765

Site Contact

Francis Averill, MD

faverillresearch@stfrancismed.com

727-210-4606

Emory University Hospital, Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital

Atlanta, Georgia, 30322

Site Contact

Mitzi Near, RN

mnear@emory.edu

404-712-9603

Tulane University School of Medicine, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University School of Medicine

New Orleans, Louisiana, 70112-2600

Site Contact

Joseph Lasky, MD

jlasky@tulane.edu

504-988-2251

Minnesota Lung Center, Edina, Minnesota

Status

Completed

Address

Minnesota Lung Center

Edina, Minnesota, 55435

Minnesota Lung Center, Minneapolis, Minnesota

Status

Recruiting

Address

Minnesota Lung Center

Minneapolis, Minnesota, 55407

Site Contact

Susan MacKinnon

sue.mackinnon@mlcmsi.com

952-852-5342

The Lung Research Center, Chesterfield, Missouri

Status

Recruiting

Address

The Lung Research Center

Chesterfield, Missouri, 63017

Site Contact

Anna Shipp, RRT

Anna.shipp@stlukes-stl.com

314-682-3653

Brooklyn, New York

Status

Recruiting

Address

New York University Langone Pulmonary and Critical Care Associates

Brooklyn, New York, 11209

Site Contact

Julia Cirillo

julia.cirillo@nyulangone.org

929-455-5970

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Maria Padilla, M.D.

Maria.padilla@mssm.edu

212-241-5656

Pulmonix, Greensboro, North Carolina

Status

Recruiting

Address

Pulmonix

Greensboro, North Carolina, 27403

Site Contact

Murali Ramaswamy

Murali.ramaswamy@pulmonix.com

336-522-8870

Salem Chest Specialists, Winston-Salem, North Carolina

Status

Recruiting

Address

Salem Chest Specialists

Winston-Salem, North Carolina, 27103-4007

Bethlehem, Pennsylvania

Status

Recruiting

Address

Saint Luke's University Hospital - Bethlehem

Bethlehem, Pennsylvania, 18015

Temple University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University Hospital

Philadelphia, Pennsylvania, 19140

Site Contact

Gerard Criner

breathe@tuhs.temple.edu

215-707-1359

The Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

The Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Robyn Empey

recruitment@musc.edu

843-792-4691

Franklin, Tennessee

Status

Recruiting

Address

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067

Dallas, Texas

Status

Recruiting

Address

Baylor Scott & White Center for Advanced Heart & Lung Disease

Dallas, Texas, 75226

Site Contact

Felicia Padilla

Felicia.Padilla@BSWHealth.org

214-820-1771

Baylor College of Medicine, Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Site Contact

Sangeeta Shenoy

sangeeta.shenoy@bcm.edu

215-820-5440

Metroplex Pulmonary and Sleep Center, McKinney, Texas

Status

Recruiting

Address

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069

Site Contact

Shahrukh A, Kureishy

Shahrukh_kureishy@yahoo.com

972-954-6002

Inova Fairfax Medical Campus, Falls Church, Virginia

Status

Recruiting

Address

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

Site Contact

Christina Good

Christina.Good@inova.org

703-776-5444

MedStar Georgetown University Hospital, Georgetown, Washington

Status

Recruiting

Address

MedStar Georgetown University Hospital

Georgetown, Washington, 20007