A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS

Date Added
September 8th, 2021
PRO Number
Pro00114065
Researcher
Timothy Whelan

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of PRM-151 versus placebo on patients with IPF during a 52-week period.. This study is testing an experimental drug called recombinant human pentraxin-2 (rhPTX-2; also known as PRM-151 or RO7490677). About 658 people will take part in this study.

Institution
MUSC
Recruitment Contact
Allison Patterson
(843) 792-5168
patteall@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Date Added
July 6th, 2021
PRO Number
Pro00109809
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The study is divided into a Screening Period (up to 4 weeks), Double-Blind Placebo-Controlled (DBPC) Treatment Period (24 weeks), a Long-Term Double-Blind (LTDB) Treatment Period (until last participant completes the DBPC treatment period, up to approximately 72 weeks), and a Follow-Up Period (at least 8 weeks). Approximately 284 research participants will participate in this study. These participants will be enrolled at approximately 191 clinical centers around the world.

Institution
MUSC
Recruitment Contact
Abigail Grady
(843) 792-2072
gradyabi@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study

Date Added
May 6th, 2021
PRO Number
Pro00109905
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of the study drug, brensocatib, as treatment for NCFBE. This is a double-blinded study.
The maximum study duration is 62 weeks total for an individual participant, including a Screening Period of up to 6 weeks, a Treatment Period of 52 weeks, and an End-of-Study Visit 4 weeks following the end of treatment. Approximately 1,620 subjects between the ages of 18 and 85 years, with diagnosed NCFBE are expected to participate in this study. The study is being conducted at approximately 480 centers in North America, Europe, Japan, and the rest of the world. All subjects will complete the same study procedures. The study will last approximately 62 weeks from the Screening (Visit 1) to the End of Study (Visit 12). There will be 12 visits including the Screening Visit (1 visit), Study Treatment Visits (10 visits: 6 visits are in the study clinic [Visits 2, 3, 5, 7, 9, and 11], and 4 visits by telephone from your home [Visits 4, 6, 8, and 10]), and an End of Study Visit (1 visit). The End of Study Visit (Visit 12) will occur in the study clinic.

Institution
MUSC
Recruitment