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.
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 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 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.
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.
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.
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.
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.
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.
Following the study Entry Visit, subjects will return at Week 4,
Week 12, and every 12 weeks thereafter. Study visits will continue
for up to 6 years or until the subject prematurely discontinues study
treatment due to an adverse event or other reason, inhaled treprostinil
becomes commercially available for IPF in the region in which the
study is conducted, or the study is discontinued by the Sponsor
(whichever is sooner). Subjects will also be contacted by telephone or
email at least weekly until Week 12 and monthly thereafter in
between study visits to discuss study drug titration, assess study drug
tolerability, monitor adverse event, document changes to concomitant
medications, and remind subjects to bring in all study drug and a
device to their next clinic visit.