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.
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.
The purpose of this study is to test whether a drug called efzofitimod (the study drug) is a potential treatment for patients with Systemic Sclerosis associated with Interstitial Lung Disease (SSc-ILD).
Efzofitimod is an investigational drug that is given by infusion every 4 weeks for a total of 6 doses. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, efzofitimod will be compared with a placebo (dummy drug). The placebo will be a saline solution that does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of efzofitimod or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know what you are receiving, the study efzofitimod or placebo.
The study is sponsored by aTyr Pharma, Inc. Participation in the study will require 9 visits to the MUSC main campus and will have the following procedures completed over the course of your participation: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as asked to complete surveys.
Compensation is available for participation
This is a randomized, double-blind, dose-ranging, placebo-controlled study to see how effectively and how safely two different doses of bexotegrast (160 and 320 mg) can be taken every day for 52 weeks (about 12 months) by subjects with IPF (Idiopathic Pulmonary Fibrosis) who are taking or not taking background therapy (other drugs for IPF include nintedanib or pirfenidone). The study is designed to test the study drug in subjects who are taking or not taking background therapy and will include about 80 subjects who are not taking background therapy at study entry. Subjects who are not taking background therapy at study entry will be allowed to start it at any time during the study. The study will consist of an up to 28-day Screening Period, a 52-week Treatment Period, and a 14-day Safety Follow-up Period. Participants will undergo an end-of-study visit at the end of the Safety Follow-up Period.
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of the study drug DWN12088 in patients with idiopathic pulmonary fibrosis (IPF), with or without standard-of-care. Patients meeting the eligibility criteria for the study will be randomized with a 2:1 ratio to DWN12088 150 mg BID or the matching placebo. This study will have 8 study visits over a period of a maximum of 36 weeks. This study period includes a maximum 8-week screening period, a 24-week treatment period and a 4-week follow-up period. The duration of each visit will vary depending on the procedures performed.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study that will randomize participants with Progressive Pulmonary Fibrosis to study drug BMS-986278 60mg, 120mg, or Placebo, administered orally, twice a day. Participants are allowed to continue background therapy, such as antifibrotic and immunosuppressant therapies. This study will consist of two parts (Cohort 1 and 2). Cohort 1 will enroll approximately 60 participants with Progressive Pulmonary Fibrosis to evaluate the safety and tolerability of BMS-986278 in which participants will be randomized to receive 60 mg, 120mg, or placebo and this will last approximately 52 weeks. Cohort 2 is a registrational, double-blinded study which will investigate the efficacy, safety, and tolerability of BMS-986278 compared with placebo. Based on data from Cohort 1, the study will design 2 or 3 treatment arms for Cohort 2.