Clinical Studies
VX21-522-001: A Phase 1 Single Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
Principal Investigator: Joanne Billings
Evaluate the safety and tolerability of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy. Currently recruiting.
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Principal Investigator: Hyun Kim
Description: The purpose of this trial is to evaluate the efficacy, safety, and tolerability of BI 1015550 9 mg bid and 18 mg bid compared to placebo in patients with progressive fibrosing ILDs in addition to patient’s standard of care over the course of at least 52 weeks. New treatments with better tolerability are needed for patients with ILDs to further reduce the decline in lung function and improve quality of life. Based on its anti-inflammatory and antifibrotic properties and the preliminary clinical evidence described, BI 1015550 may provide an additional treatment option to patients with progressive pulmonary fibrosis irrespective of concomitant treatment with standard of care. Currently recruiting.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients with Pulmonary Sarcoidosis
Principal Investigator: Maneesh Bhargava
Description: We are studying the use of Efzofitimod given IV at two different doses to treat people who have pulmonary sarcoidosis. Participants must be on stable treatment with an oral corticosteroid with or without immunosuppressant therapy. Some people will receive IV saline (placebo) and we will compare groups to see how well the drug works and what side effects occur. The trial will last for about one year. Currently recruiting.
R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis
Principal Investigator: Maneesh Bhargava
Description: This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis, and to compare those with healthy controls. Currently recruiting.
A Prospective, Multi-Center, Single-Arm, Open-Label, Observational Study on the Safety and Effectiveness of the ProSomnus EVO Sleep and Snore Device in the Treatment of Severe Obstructive Sleep Apnea
Principal Investigator: Bimaje Akpa
Currently Recruiting
Description: The primary objectives of this study are to evaluate the therapeutic effectiveness and safety profile of the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea (OSA). The secondary objective is to evaluate the effect of the EVO Sleep and Snore Device on Epworth Sleepiness Scale (ESS) scores.
The Lung Cell Study (TLC)
Principal Investigator: Monica Campo-Patino
Currently Recruiting
Description: The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.
Sightline: Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.
Principal Investigator: Abbie Begnaud
Currently Recruiting
Description: This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study includes two phases: Lung EpiCheck assay development and clinical validation. Samples collected under this protocol will support both phases. The study includes two subject groups: a Cases Series and a Screening Series.
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF (STRONG-CF)
Principal Investigator: Joanne Billings
Currently Recruiting
Description: There are currently two main ways of measuring nutrition in the Cystic Fibrosis (CF) population: body mass index (BMI) and laboratory values. This study plans to look at more ways to measure nutrition, and body composition, like the percentages of fat, bone and muscle in your body. One of the ways we will measure these items is by using dual energy X-ray absorptiometry (DXA) scan, which is a type of x-ray. This study hopes to provide researchers with more detailed information about nutrition and body composition in adults with CF.
20-0001: A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa
Principal Investigator: Joanne Billings
Currently Recruiting
Description: We are looking at a new intravenous drug, Bacteriophage, to treat Pseudomonas Aeruginosa in people at least 18 years of age who have cystic fibrosis. The drug is given one time and different doses will be evaluated to see if they work and to look at side effects.
KIN-1902-2001: A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis (RESOLVE-Lung)
Principal Investigator: Maneesh Bhargava
Currently Recruiting
Description: We are studying a new medication, namilumab, given to treat Chronic Pulmonary Sarcoidosis. We are looking at the effectiveness, how well the drug is tolerated, and the side effects that occur. For the first part of the study, some people will receive the namilumab; the others will receive an inactive (placebo) drug. In the second part of the study, everyone may receive the namilumab.
RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)
Principal Investigator: Joanne Billings
Currently Recruiting
Description: We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.
T3 : Phase II Randomized, Intervention Versus Non Intervention, Multi-center Study of the Effects of Thyroid Hormone (T3) on Safety/Tolerability and Oxygenation in Subjects with Acute Respiratory Distress Syndrome (ARDS)
Principal Investigator: Ronald Reilkoff
Currently Recruiting
AIMS - Assessment of Implementation Methods in Sepsis and Respiratory Failure (AIMS) Study. Randomized, Parallel Assignment Hybrid 2 implementation effectiveness trial with a cluster randomized control trial.
Principal Investigator: Ronald Reilkoff
Currently Recruiting
Description: Evaluating effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and examining the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle.
A Phase 2, Double-Blind, Randomized, ActiveControl, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults
Principal Investigator: Ronald Reilkoff
Currently Recruiting
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
Principal Investigator: David Wacker
Currently Recruiting
Description: The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway.
A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)
Principal Investigator: Hyun Kim
Currently Recruiting
Description: A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry
Principal Investigator: Hyun Kim
Currently Recruiting
Description: This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.
A Randomized, Doubleblind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
Principal Investigator: Hyun Kim
Currently Recruiting
Description: Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Prospective tReatment EffiCacy in IPF uSlng genOtype for Nac Selection (PRECISIONS) trial and Molecular Endophenotyping in Idiopathic Pulmonary Fibrosis and Interstitial Lung Diseases study
Principal Investigator: Hyun Kim
Active, not recruiting
Description: The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function [10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality].
The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.
Nintedanib Pharmacogenomics in Idiopathic Pulmonary Fibrosis (IPF)
Principal Investigator: Hyun Kim
StudyFinder is a University of Minnesota website that displays a searchable listing of studies, which are extracted from ClinicalTrials.gov. At StudyFinder you can explore University health studies currently seeking participants.
Clinicaltrials.gov is a database of privately and publicly funded clinical studies conducted around the world.