A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Date Added
December 10th, 2025
PRO Number
Pro00147707
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD)
Summary

This study will see if the experimental medicine MTX-463 can slow or stop idiopathic pulmonary fibrosis (IPF) from worsening in people at least 40 years of age or older. Participants will receive either MTX-463 or a placebo (which contains no active drug) through an intravenous infusion once every 4 weeks, for a total of 6 infusions. Overall, participants will attend a total of 9 visits over the course of approximately 32 weeks, or roughly 8 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

Feasibility and Acceptability of A Mobile Application "SUPPORT-T" to increase access to Palliative Care in patients with Progressive Pulmonary Fibrosis (PPF) and their Caregivers.

Date Added
September 10th, 2025
PRO Number
Pro00146761
Researcher
Kathleen Lindell

List of Studies

Keywords
Education, Interstitial Lung Disease (ILD)
Summary

The goal of this research study is to explore and evaluate the acceptability and feasibility of a 8-week, nurse-led Palliative Care program (SUPPORT-T) delivered over the internet to help educate and support individuals with Progressive Pulmonary Fibrosis (PFF) and their caregivers. In this study, we will enroll 80 PFF patients and 80 careparnters (total N=160 participants) who will then either receive the online SUPPORT-T program or enhanced usual care (educational handouts). At the end of the study, 15 PFF patients and caregivers who received SUPPORT-T and 5 community partners will take part in one-on-one interviews with the researchers to provide their feedback on the program; so as to improve it for a larger study. This study is being conducted by the Medical University of South Carolina in South Carolina and Mount Sinai Hospital in New York.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-792-3512
pittmama@musc.edu

A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Date Added
July 9th, 2025
PRO Number
Pro00144899
Researcher
Denise Gabrielle Sese

List of Studies

Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

The purpose of this study is to observe and capture demographic characteristics,
treatment patterns, and clinical outcomes of interest for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. This study will follow patients for up to 5 years after enrollment.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis

Date Added
June 17th, 2025
PRO Number
Pro00145146
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD), Lung, Pulmonary
Summary

This study will compare the safety, tolerability, and efficacy of inhaled study drug LTI-03 to placebo in participants diagnosed with IPF within 5 years of Screening who may be receiving standard of care (SoC) antifibrotic therapy. Taking part in this research is expected to last up to 32 weeks, which includes a 4-week screening period, a 24-week treatment period, and 4-week post-treatment follow-up period. The general procedures include review of eligibility; review of medical and medication history and changes in health; completing questionnaires; undergoing physical exams and having vital signs measured; collecting blood samples; examinations such as ECG, spirometry, HRCT, and DLCO and using an inhaler to take the study drug.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Date Added
December 6th, 2024
PRO Number
Pro00140922
Researcher
Rahul Argula

List of Studies


Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

This study is investigating the drug, called mosliciguat, for the treatment of PH-ILD. Participation in the study may last for about 4 ½ years, although the actual time of participation may be shorter or longer. Part 1 of the study will take about 6 months. Part 2 of the study could last up to about 4 years. During the study, participants will be required to make clinic visits in person and at times will need to meet with study staff over the phone/video. At some of the clinic visits, participants will have blood drawn and have procedures to test their lungs and heart function. Participants will be randomly assigned to get mosliciguat or placebo in Part 1. In Part 2, all participants will get mosliciguat. Approximately 120 people will participate in this study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)

Date Added
September 17th, 2024
PRO Number
Pro00136737
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in subjects with Progressive Pulmonary Fibrosis (PPF) over 52 weeks. Subjects will participate in the study for up to 58 weeks, inclusive of a Screening Period of up to 4 weeks, a 52-week Treatment Period, and a 2-week Follow-up Period that includes a Follow-up telephone call (TC) 2 weeks post final dose. Up to 300 eligible subjects will be randomized in a 2:1:2 ratio to 1 of 3 treatment arms: AP01 100 mg twice daily (BID), AP01 50 mg BID, or placebo BID (8 mL; two 4 mL blow-fill-seal [BFS] ampoules BID).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)

Date Added
March 27th, 2024
PRO Number
Pro00134693
Researcher
Rachana Krishna

List of Studies


Keywords
Drug Studies, Interstitial Lung Disease (ILD), Pulmonary
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, efficacy and safety study of subjects with PPF (Progressive Pulmonary Fibrosis) treated with inhaled treprostinil over a 52-week period. This study is investigating whether a drug called inhaled treprostinil (brand name Tyvaso®) works to help people with PPF improve their lung function tests. The purpose of this research study is to see how well inhaled treprostinil works in participants with PPF and to gather information on how safe it is. This study will look at changes in your breathing tests, also called lung function tests. About 698 people will participate in this study from about 150 medical centers. Your participation in this study is voluntary and will last approximately 58 weeks. This time includes a Screening Period that could last up to approximately 6 weeks plus a 52-week Treatment Period.

Institution
MUSC
Recruitment Contact
Robyn Empey
8437920965
recruitment@musc.edu

Medical University of South Carolina Interstitial and Connective Tissue Associated Lung Disease Biobank (MUSICAL)

Date Added
August 9th, 2023
PRO Number
Pro00127647
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD), Lung
Summary

The purpose of this study is to learn more about interstitial lung disease through collection of information and blood samples to be used in future research projects. Basic information and a blood sample will be collected in conjunction with clinical care for this study, approximately every 3 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

A PHASE 3, OPEN-LABEL, RANDOMIZED, STANDARD OF CARECONTROLLED, PARALLEL ARM STUDY TO DEMONSTRATE EFFICACY AND SAFETY OF ARINA-1 IN THE PREVENTION OF BRONCHIOLITIS OBLITERANS SYNDROME PROGRESSION IN PARTICIPANTS WITH BILATERAL LUNG TRANSPLANT

Date Added
February 8th, 2023
PRO Number
Pro00126240
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The study will be an open-label, randomized, parallel arm study that will include a
treatment arm and control arm. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44. The phone calls may be converted to telehealth visits or clinic visits and / or followed by clinic visits, if the study team deems it necessary. Pulmonary function testing, quality of life survey (St. George's Respiratory Questionnaire (SGRQ)), and blood draw will occur at each clinic visit.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO) and Interstitial Lung Disease Prospective Outcomes (ILD-PRO) Registry

Date Added
May 13th, 2014
PRO Number
Pro00033910
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The purpose of this research registry is to better understand the natural history of Idiopathic Pulmonary Fibrosis and current practice patterns. The IPF-PRO registry will be used to collect data and biological samples that will support future research studies by identifying disease biomarkers for IPF. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some of these studies may be about how genes affect health and disease, or how a person's genes affect their response to a treatment. Some of these studies may lead to new products, such as drugs or tests for diseases. We are asking you to let us collect and store some of your blood and health information so they might be used in these kinds of future studies.

If you are newly diagnosed with IPF and are eligible for participation in IPF-PRO, you will be asked to sign a consent form to become enrolled if you agree to be in this registry. At enrollment a member of MUSC research staff will collect information from you and about your medical history and medical care, as well as information about the types of health insurance (public or private) that you have. As part of your participation in this registry, you will be required to sign a medical release form giving permission for your medical records to be reviewed for the purposes of data collection for the registry. This is an observational registry which means you will not receive any investigational treatments or investigational drugs, and only minimally invasive procedures will be performed (blood draws) at scheduled clinic visits. In addition to the face to face visits for self-administered participant reported questionnaires and blood collection, at roughly 6-month intervals, sites will review the participant's medical records. Your disease management and treatment decisions will be determined by you and your health care professional. Subjects will be followed until the last enrolled subject has been followed for 3 years up to a maximum of 5 years.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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