A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

Date Added
January 24th, 2025
PRO Number
Pro00142015
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)

Date Added
February 7th, 2025
PRO Number
Pro00136819
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

Part A of this study will compare the effects of Clofazimine Inhalation Suspension to placebo. The purpose of this study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from the lungs and to make sure that Clofazimine Inhalation Suspension is safe for use. The participant will continue with current treatment for NTM lung disease in this study. To test if the bacteria are gone from the lungs, sputum will be tested on a regular basis (every month) to see if the culture changes from positive to negative. Participants will be randomly assigned by chance (like drawing numbers from a hat) to either Clofazimine Inhalation Suspension or placebo.

After the participant completes the study treatment in Part A, they will be eligible to receive Clofazimine Inhalation Suspension in Part B.

Approximately 234 participants will take part in the study at approximately 120 sites globally.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

CRISPR detection of circulating cell-free Mycobacterium avium complex (MAC) DNA for rapid diagnosis and monitoring of MAC pulmonary disease

Date Added
March 5th, 2025
PRO Number
Pro00140587
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

The study includes both a retrospective cross-sectional and prospective longitudinal cohort study design. Demographic and clinical data will be obtained through medical record review. 3-4 blood draws will be collected over the course of the study. If participants were also in the MAC2v3 or NTM PRO Cohort study, data collected for that study will be used in this study. About 450 subjects are expected to participate in this study at 7 research sites in the United States. Participation in this study is expected to last up to 12 months. During that time, participants will have about 3-4 study visits.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu



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