A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)

Date Added
August 6th, 2026
PRO Number
Pro00151414
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD)
Summary

DROP-FPF is a clinical study that will assess whether an investigational medication called nerandomilast can reduce the risk of interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) getting worse over time. By learning more about people with early lung abnormalities, it may inform researchers how to reduce the risk of developing progressive pulmonary fibrosis.

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

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (WHO Group 3)

Date Added
June 26th, 2026
PRO Number
Pro00151380
Researcher
Rahul Argula

List of Studies


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

The purpose of the Re-Spire Study is to help researchers learn more about the efficacy and long-term safety and tolerability of the research drug L606 in participants with PH-ILD.
There are two phases of the Re-Spire Study participants can potentially join with the second phase starting directly after the first phase ends. The first phase is called the "Blinded Treatment Phase" (BTP). This is the "double-blind," assigned by chance portion of the study and will last approximately 28 weeks (a 30-day Screening period followed by a 24-week study period). The second phase of the Re-Spire Study is called the "Open Label Extension Phase" (OLEP). This phase is optional. It is called "open-label" because there is no placebo and everyone who joins will take the active study drug, L606.
About 350 participants will take part in this research study from around 120 study centers or research sites in various countries or regions.

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

Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)

Date Added
May 12th, 2026
PRO Number
Pro00150785
Researcher
Aravind Menon

List of Studies

Keywords
Arthritis, Interstitial Lung Disease (ILD)
Summary

The overall objective of this proposal is to identify patients with Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) that are at the highest risk for progressive disease at the time of diagnosis. Our central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. Approximately 80 subjects will be enrolled from MUSC and participation with last up to 2 years.

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

MOMENTOUS study (iMpact Of an ecg ai ModEl oN The diagnosis Of pUlmonary hypertenSion)

Date Added
February 24th, 2026
PRO Number
Pro00148837
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

The MOMENTOUS study will test the prospective performance of the Tempus Pulmonary Hypertension ECG model within patients with interstitial lung disease (ILD) who do not have a diagnosis of Pulmonary Hypertension. The purpose of the study is to provide information on the clinical utility of this new technology within a multicenter randomized study. The study will target approximately 1000 participants completing the study over a period of 2-3 years. Study participation will consist of 4 visits over a period of 6 months.

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

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



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