A Phase 2 Multicenter, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis

Date Added
November 6th, 2023
PRO Number
Pro00132082
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical
study is designed to evaluate the safety and tolerability of 3 dose levels of TTI-101 vs placebo in participants with idiopathic pulmonary fibrosis (IPF). a screening period of up to 28 days, 100 participants will be randomly assigned to receive 1 of 3 dose levels of TTI-101 (25 participants per dose level) or matching placebo (25 participants). Enrollment will be stratified by current use of nintedanib. The assigned study drug will be self-administered orally in tablet form twice daily (BID) with a glass of water after a meal. Once randomized, each participant will maintain their current standard of care supportive medications, including cough treatment, medications for symptom relief or quality of life improvements, oxygen therapy where indicated, respiratory physiotherapy, and treatment of comorbidities. Following randomization, all participants will enter the 12-week, double-blind treatment period.

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

3P-100-ILD-00 Early Feasibility Study Protocol: A Within-subject Device-setting Escalation Early Feasibility Study Evaluating the Safety, Tolerability, and Functionality of 3P-100, an Electric Nitric Oxide (NO) Ambulatory Production and Delivery System, Delivering Nitric Oxide for Inhalation to Subjects with Pulmonary Hypertension (PH) Accompanying Interstitial Lung Disease (ILD), PH-ILD

Date Added
October 31st, 2023
PRO Number
Pro00128998
Researcher
Rahul Argula

List of Studies


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

This is a multi-center early feasibility study evaluating the safety and tolerability of the 3P-100 device which creates and delivers iNO for the treatment of subjects with PH-ILD. All subjects will use the 3P-100 device and receive iNO via the 3P-100 device, aiming for ~4-4.5 hours of treatment. All subjects will remain on their prescribed Oxygen (O2). The study consists of an SV, an iNO treatment period at V1 (Day 0), and a Telephone Call at V1 + 1 Day for safety follow-up.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
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 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as mono- or add-on therapy, in Patients with Idiopathic Pulmonary Fibrosis (IPF)

Date Added
July 25th, 2023
PRO Number
Pro00128976
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib). For both the placebo and BBT-877 groups, patients will be selected so that 40% to 60% of the patients in each group will be treated with pirfenidone or nintedanib in order to investigate if BBT-877 could be used as either monotherapy or add-on therapy to AFs, to further reduce the decline in lung function and/or improve symptoms as compared to those drugs alone. As a result, 60% to 40% of the patients will receive BBT-877 or placebo, alone.

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

Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 23rd, 2023
PRO Number
Pro00126306
Researcher
Patrick Flume

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The Program will allow access to brensocatib for patients who have completed the INS1007-301 ASPEN Clinical Trial. Patients will receive brensocatib 10 mg orally once daily. Eligible, compliant patients may receive brensocatib in this program until the drug is commercially available or until Insmed terminates the program.

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