Research Portfolio Summary

April 2024

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BMS IM027-068 – A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis Sponsor: Bristol Myers Squibb

In this study, researchers hope to learn more about a study being conducted to test the effect of BMS 986278 on improving idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis is often a chronic, progressive, and potentially fatal lung disease in which scar tissue continuously forms in the lungs. This results in persistent cough, and shortness of breath.

BMS IM027-1015 – A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis Sponsor: Bristol Myers Squibb

This study to was designed to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Progressive Pulmonary Fibrosis defined as the presence of at least two of the three criteria, which are worsening respiratory symptoms, functional decline, and radiological progression in patients with interstitial lung disease with radiological pulmonary fibrosis for known or unknown reasons other than IPF, within the previous year.

A Structured Educational Program for Patients Regarding Measures to Reduce Environmental Exposure to Nontuberculous Mycobacteria- Impact on Disease Control and Recurrence Investigator Initiated: Principal Investigator – Leah Lande, MD

The purpose of this study is to determine whether or not patients with Non-tuberculosis mycobacterium (NTM) lung infection can decrease reoccurrence or eliminate the NTM lung disease by following environmental and habitual activity instructional modifications.

Screening from High Frequency Malignant Disease (SHIELD)Sponsor: Guardant Health, Inc

The purpose of the study is to determine if a blood test called GuardantLUNAR-2 can help detect high frequency cancer or other diseases. The main goal of SHIELD is to collect health information and blood samples from people who are at average or high risk for high frequency cancer and are scheduled to have a standard of care cancer screening test.

Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (CORE-HH: Cancer ORigin Epigenetics – Harbinger Health) Sponsor: Harbinger Health

In an earlier research study, Harbinger Health developed a test that was shown to detect a variety of different cancer types. A new version of the Harbinger Health test has been developed and is investigational. The purpose of this study is to determine the accuracy of the new test in regard to cancer detection in a blood sample. Blood and tissue samples will be collected from people who have recently been diagnosed with cancer, are suspected of having a new cancer, or who are healthy to test the new version of the Harbinger Health Test. To develop a test that can tell those with cancer from those without cancer, the study must collect blood from both participants who have cancer and those that do not. Tissue from patients diagnosed with cancer will be evaluated to identify abnormalities in certain cancers and provide more information about how certain cancers appear in blood.

Sub-Phenotypes of ARDS using Rapid prospective Classification (SPARC): An Observational Study (2nd Phase) I-SPY COVID: Testing novel drugs or drug combinations to treat COVID-19 (1st Phase -Closed to Enrollment) Sponsor: Quantum Leap Healthcare Collaborative (QLHC)

The purpose of Phase 2 SPARC study is to determine whether patients with ARDS or AHRF can be rapidly classified into one of two different types at the time they are admitted to the hospital. A test of the blood collected, and clinical information will be used to classify the type of ARDS or AHRF that participants have. This is a process that could be used in subsequent future research on ARDS and AHRF.

The purpose of the initial I-Spy Covid study was to test if the antiviral drug (remdesivir) used alone or in combination with other investigational drugs can treat COVID-19. The results will be compared between treatment groups to determine which treatments work better, do not work as well as, or do not work well enough to be used for the treatment of COVID-19.

Pulmonary Embolism – Thrombus Removal with Cather-Directed Therapy (The PE-TRACT Trial) Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

The purpose of the study is to determine whether patients with submassive pulmonary embolism (PE) who are treated with Cather-Directed Therapy (CDT) plus medical therapy (CDT group) have better cardiopulmonary health in the year following PE than patients treated with medical therapy alone (No-CDT).

SLEEP DATA COLLECTION STUDY Sponsor: Apple Inc.

The objective of this study is to collect data for product research and development evaluation sponsored by Apple Inc. The study will compare the performance of the Apple Watch (“Watch”) to a medical-grade Home Sleep Apnea Test (HSAT).

Single Patient Use of Clofazimine Investigator Initiated: Principal Investigator – Leah Lande, MD

This is an opportunity for providers to prescribe patients with drug resistant Mycobacterium avium complex (MAC) with the FDA drug Clofazimine for compassionate use. Physicians apply on a case-by-case basis via an Investigational New Drug (IND) application. This allows patients with MAC an opportunity to have access to an additional drug for treatment of their resistant MAC disease.