Idiopathic Pulmonary Fibrosis

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and immune response of a drug called SV001 compared to a placebo in healthy adult volunteers from China. This early phase 1, randomized, double-blind, and placebo-controlled study aims to understand how SV001 behaves in the body and whether it causes any adverse effects. The study focuses on adults aged 18 to 45 years who are in good health. Participants will receive a single dose of either SV001 or a placebo. The study uses a dose-escalation design, meaning doses may increase to assess safety. The trial is conducted at a single center and uses a quadruple-blind method where participants, care providers, investigators, and outcome assessors are unaware of which treatment is given. The intervention period includes administration of the study drug followed by monitoring. During the study, participants will undergo various assessments including monitoring for any treatment-emergent adverse events, measuring drug levels in the blood over time, and checking for immune responses to SV001. These evaluations will take place over approximately one year. Researchers will also monitor participants overall health, respiratory function, and conduct laboratory tests to ensure safety throughout the trial.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Coughing is a common and distressing symptom for people with interstitial lung disease ILD, affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapys impact and participants experiences.

Researchers are studying HW241045 in a Phase Ia clinical trial to evaluate its safety, tolerability, and how it is processed in the body after a single dose. This randomized, double-blind, placebo-controlled study involves healthy adult volunteers aged 18 to 55 years to better understand the effects of this drug compared to a placebo. Participants will receive a single oral dose of either HW241045 or a placebo. The study is designed with two groups one receiving the experimental drug and the other receiving placebo, both under blinded conditions to ensure unbiased results. The trial is conducted at a single center and uses a quadruple masking approach. During the study, participants will be closely monitored for any treatment-emergent adverse events within 48 hours after dosing. Assessments include safety checks, tolerability evaluations, and pharmacokinetic measurements. Participants health will be carefully observed during this period to understand the drugs effects and side effects. The total duration of participation is determined by these assessments and monitoring schedules.

Researchers are evaluating a digital self-management package called REBUILD-SM designed for people with interstitial lung disease ILD. The study aims to find out whether REBUILD-SM can improve health-related quality of life, symptoms, anxiety, self-confidence in managing illness, and physical activity levels compared to standard care. REBUILD-SM combines a smartphone app with a self-management program developed in collaboration with people living with ILD to support better disease management. Participants in the intervention group will use the REBUILD app to enter and track health data such as diagnosis, medications, lung function, and oxygen use. They will also work through 13 self-management modules at their own pace with support from healthcare professionals through four phone or Zoom calls over a 12-week period. The control group will use a simpler version of the app for data entry only and receive calls without health advice. After 26 weeks, control participants will gain access to the full app but not the self-management content or support calls. During the study, participants will complete questionnaires and update their health data at baseline, 12, 26, and 52 weeks. Electronic reminders and follow-up calls will encourage questionnaire completion. Researchers will measure changes using questionnaires on lung disease impact, quality of life, anxiety, physical activity, and self-efficacy. The main outcome is change in the Kings Brief Interstitial Lung Disease questionnaire score at 12 weeks. The study includes ongoing monitoring up to 52 weeks to assess longer-term effects and app usability.

Researchers are evaluating the safety and tolerability of inhaled mosliciguat combined with inhaled treprostinil in adults with pulmonary hypertension associated with interstitial lung disease PH-ILD. This Phase 2, open-label, multi-center study focuses on participants who already use inhaled treprostinil to manage their condition. The trial aims to gather important safety information about this combination treatment in this specific lung disease population. Participants will receive daily inhaled mosliciguat during a 16-week open-label treatment period. After this period, those who complete the initial phase may continue to receive mosliciguat in an extension phase lasting beyond 16 weeks. Mosliciguat will be delivered using a dry powder inhaler device, and doses may vary among three different levels. All participants will continue treatment with inhaled mosliciguat during the extension. Throughout the study, researchers will monitor participants for treatment-emergent adverse events, serious adverse events, and any side effects leading to discontinuation, with assessments at baseline and at week 16. Participants must be able to perform a six-minute walk of at least 100 meters. The study includes imaging confirmation of interstitial lung disease and right heart catheterization to confirm pulmonary hypertension. The total participation duration may extend beyond 16 weeks depending on continuation in the extension phase.

Researchers are studying the natural progression of Interstitial Lung Disease ILD and related conditions such as Idiopathic Pulmonary Fibrosis, Sarcoidosis, and Connective Tissue Disorder. The goal is to collect detailed data and blood samples from patients receiving care in the ILD program as well as from a control group to better understand the different ways these diseases can appear and progress over time. Participants in this observational study will not receive a specific treatment but will contribute data and blood samples over time. This approach allows researchers to compare disease characteristics in affected patients with those in healthy controls, aiming to describe the phenotypic expression of these lung diseases. Throughout the study, participants will have yearly evaluations to track the natural history of their lung disease. Data collection will include clinical assessments and blood samples to monitor disease progression. The study is ongoing, with participation potentially lasting for many years, allowing for long-term observation of the disease course.

Researchers are studying idiopathic pulmonary fibrosis IPF by evaluating how the investigational drug taladegib ENV-101 interacts with current standard treatments, nintedanib and pirfenidone. The study also aims to understand how taladegib is absorbed, distributed, metabolized, and eliminated by the body. This phase 1, open-label study involves healthy adult participants and is sponsored by Endeavor Biomedicines, Inc. The study consists of four groups, each receiving different treatment regimens. One group takes nintedanib twice daily to observe its impact on a single dose of taladegib. Another group takes pirfenidone three times daily for this purpose. A third group receives multiple days of taladegib to assess its effect on a single dose of pirfenidone. The last group receives a single dose of taladegib to measure its pharmacokinetic profile. Each group undergoes treatment for up to 30 days, followed by a 14-day safety follow-up period. Participants will stay at the clinical site for a specified time depending on their group, during which they will take the study drugs as scheduled. Researchers will measure drug levels in the blood at various time points to assess absorption and elimination characteristics. Safety evaluations will continue during the follow-up period after treatment ends. Overall, the study duration varies by cohort, with the longest treatment lasting 30 days plus 14 days of follow-up, ensuring careful monitoring of drug interactions and participant safety.

Researchers are studying SRN001, a new small interfering RNA drug designed to reduce fibrosis by targeting amphiregulin, a growth factor involved in fibroblast activity in lung and kidney tissues. This phase 1 clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeated SRN001 doses in healthy adult males who are Korean or Caucasian. Participants will receive one of three doses of SRN001 45 mg, 90 mg, or 180 mg or a placebo 0.9% sodium chloride solution in a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study. The trial compares these groups to understand how SRN001 is processed in the body and its effects at different dose levels. During the study, participants will be monitored for treatment-emergent adverse events, serious adverse events, and abnormal lab results over up to 114 days. Blood samples will be collected at specific times before and after dosing to measure drug concentration and pharmacokinetic parameters. The trial includes careful safety monitoring and evaluation of how the body absorbs, distributes, metabolizes, and eliminates SRN001.

Researchers are evaluating two different doses of CHF10067 zampilimab to assess their effectiveness, safety, and tolerability in adults with idiopathic pulmonary fibrosis IPF. This phase IIb, multicenter, randomized, double-blind, placebo-controlled study involves 240 participants across about 150 sites worldwide. The study focuses on changes in lung function, specifically percent predicted forced vital capacity ppFVC, at Week 24. Participants will be randomly assigned to one of three groups receiving either one of two doses of CHF10067 or a placebo, all administered via intravenous infusion. The study treatment is given over a 24-week period, with evaluations at several points including Weeks 6, 12, 18, 24, and 30. This design allows comparison of the drug doses against placebo while monitoring drug levels and effects over time. During the study, participants will undergo lung function tests, oxygen saturation measurements, and complete questionnaires related to living with pulmonary fibrosis. Blood samples will be taken to measure drug concentration. Various outcome measures such as absolute and relative changes in lung function and symptom assessments will be collected up to Week 30. Safety and tolerability will be closely monitored throughout the study period.