Filter Results

Clinical Studies

Open

Closed for Enrollment

  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients with Pulmonary Sarcoidosis Rochester, Minn.

    The purpose of this study is to assess the effictiveness, safety and tolerability of efzofitimod in patients with pulmonary sarcoidos, and to explore the utility of serum biomarkers in the evaluation of interventions to treat pulmonary sarcoidosis.
  • A Phase III Open-label Extension Study to Evauate Long-term Safety and Efficacy of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis (IPF) Rochester, Minn.

    The purpose of this study is to confirm the long-term safety, effectiveness, and pharmacokinetics of PRM-151 in the treatment of eligible patients with IPF who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Additionally, patients who have discontinued treatment from or have completed Study WA42293 and do not want to receive open-label PRM-151 in this study, will be invited to enroll in survival follow-up. Patients in Cohort C will not receive any treatment and will not undergo any safety or efficacy assessments during the study.
  • A Phase III Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis Rochester, Minn.

    The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of PRM-151 compared with placebo in patients with idiopathic pulmonary fibrosis (IPF). Specific objectives and corresponding endpoints for the study are outlined below.

     
  • 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 Rochester, Minn.

    The purpose of this study is to evaluate the effectiveness of namilumab in subjects with chronic pulmonary sarcoidosis (CPS).

    Sarcoidosis is a multi-organ autoimmune disease characterized by non-necrotizing granulomas believed to be formed from an exaggerated immune response to unidentified antigens. 
  • A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis (SPIRIT) Rochester, Minn.

    The primary purpose of this study is to evaluate the effectiveness of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF).

    The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.
  • B-Cells Contribute to the Development of Lung Fibrosis in a Subset of Patients with Diffuse Interstitial Lung Diseases Rochester, Minn.

    The purpose of this study is to investigate the possibility that B lymphocytes (a kind of white blood cell ) may be contributing to the development of fibrosis in the lungs. This study will examine if B lymphocytes, isolated from  blood, can induce the stimulation of fibroblasts. Fibroblasts are cells that are responsible for the formation of scarring in the lungs. Specific markers found in the surface of B lymphocytes will also be investigated to see if it can be identified why these cells may induce the development of fibrosis.

     
  • Immune Cell Activation of Healthy Human Subjects Rochester, Minn.

    The purpose of this research study is to establish a pool of healthy donors who will regularly participate in our research studies of human immunity. The studies in our laboratory investigate the role of human blood cells in immunity to fungal disease and lung fibrosis. Most of our studies require blood that is freshly drawn. Thus, we propose to draw blood on an as needed, ongoing basis.
  • Microbiome of Infectious Pleural Diseases Rochester, Minn.

    The purpose of this study is to identify potential pathogens in parapneumonic effusions associated with community acquired pneumonia and health care acquired pneumonia.
  • Registry for Advanced Sarcoidosis (ReAS) (ReAS) Rochester, Minn.

    The primary objective of this study will be to determine the clinical course of various manifestations of advanced sarcoidosis. 
  • Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH) (RESAPH) Rochester, Minn.

    The purpose of this study is to form a registry to follow patients with sarcoidosis associated pulmonary hypertension
  • Understanding Pulmonary Fibrosis using iPSC Technology Rochester, Minn.

    The purpose of this study is to obtain lung fibroblasts (a cell type that participates in fibrosis of the lung) to study then in the laboratory to identify why they are different from fibroblast from normal individuals.

    Once these cells are obtained, they will be grown in culture plates in the laboratory to be developed into many different cell types. These cells will be evaluated for their function in the laboratory, and to determine if they can continue to grow/function. Any cells that are left will be frozen for use in future experiments.
.