A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection

Date Added
October 11th, 2022
PRO Number
Pro00123010
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This study is a randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and tolerability of twice daily inhaled bacteriophages (BX004-A) for up to 10 days in 32 outpatient adult Cystic Fibrosis subjects with chronic PsA pulmonary infections who are currently receiving inhaled antibiotics. This study consists of a screening period and a treatment period, divided into 2 parts. In Part 1, subjects will receive the study drug over 7 days, in part 2 over 10 days. Subjects in both parts will be included in a 6-month safety follow-up. Final safety assessments will include phone calls 28 days and 6 months after the last dose of study medication. Questionnaires will be administered through 28 days after the last dose of study medication. A Data Monitoring Committee (DMC) will monitor safety during both parts of the study.

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

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease (MACrO2)

Date Added
December 14th, 2022
PRO Number
Pro00124613
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

This is a pivotal Phase 2/3, double-blind, placebo-controlled study of oral study drug epetraborole + OBR (Optimized background regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. A total of approximately 314 patients will be enrolled in this Phase 2/3 study. For the Phase 2 and Phase 3 parts of the study, the duration of study participation for each patient, not including
Screening, will be up to approximately 19 months. During the conduct of the study, an independent Data and Safety Monitoring Board (DSMB) will be responsible for periodic review of unblinded study safety data by performing a qualitative and quantitative safety assessment.

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

Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 23rd, 2023
PRO Number
Pro00126306
Researcher
Patrick Flume

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

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.

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

A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase 2, Dose- Ranging Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared with Placebo for the Treatment of Patients with Mycobacterium avium Complex (MAC) Pulmonary Disease

Date Added
March 28th, 2023
PRO Number
Pro00126981
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

This is a Phase 2, multicenter, randomized, double blinded, placebo-controlled study to evaluate the efficacy, safety, tolerability, and PK of two dose levels of SPR720 compared with placebo for the treatment of patients with NTM-PD due to MAC. 31 patients 18 years and older with a diagnosis of NTM-PD due to MAC will be enrolled and treated for 56 days (about 27 treatment naive, treatment inexperienced patients with NTM-PD will be randomized in a 1:1:1 ratio to receive placebo, SPR720 500 mg, or SPR720 1000 mg in a blinded manner.
Sparse PK Group (Treatment Arms 1-3): For all remaining patients, Sparse PK blood samples will be collected pre-dose (no greater than 1 h prior to dosing) on Days 7, 14 and 28; and post- dose on Day 14 (at 1 h, and 3 h), and just before discharge from the clinic (at least 6 h post- dose).

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

A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas aeruginosa Infection

Date Added
June 14th, 2023
PRO Number
Pro00128304
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of AP-PA02 administered by inhalation. This study will evaluate AP-PA02 administration in stable NCFB (non-cystic fibrosis bronchiectasis) patients. Subjects will either be included in Cohort A or Cohort B. For Cohort A, subjects will be randomized to receive either inhaled AP-PA02 or placebo. Cohort A will include individuals with NCFB and confirmed chronic P. aeruginosa infection but not on chronic inhaled antibiotics. These individuals will receive wither AP-PA02 or placebo for 10 days twice a day.
Cohort B will include individuals who with NCFB and confirmed P. aeruginosa infection but who are on chronic antibiotics. These individuals will receive either AP-PA02 or placebo for 10 days plus their current inhaled antibiotics for 28 days.

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

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

Date Added
June 27th, 2023
PRO Number
Pro00129073
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending doses (SAD) of VX-52 in patients with Cystic Fibrosis and the CFTR genotype who have not been responsive to CFTR modulator therapy. This is a first in human study.

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

Efficacy and safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4mg) once-weekly compared to tirzepatide 15 mg s.c. once-weekly in participants with obesity

Date Added
November 1st, 2023
PRO Number
Pro00131916
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

An 81-week clinical research study to compare the effect on body weight loss of CagriSema 2.4 mg vs. tirzepatide (known as Mounjaro) 15 mg weekly, along with a reduced-calorie diet and increased physical activity in participants with obesity.
The medicines are injected subcutaneously (under the skin) once a week.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu



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