Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

Launched by MERCK SHARP & DOHME LLC · Nov 3, 2022

Keywords

ClinConnect Summary

The INSIGNIA-PH-COPD study is looking into a new treatment called MK-5475 for adults who have pulmonary hypertension (PH) due to chronic obstructive pulmonary disease (COPD). The main goal of the study is to see if taking MK-5475 can help people walk farther in just 6 minutes after 24 weeks, compared to those who receive a placebo (a treatment without the active drug). Researchers hope this could improve the quality of life for those living with these conditions.

To participate, individuals must be between 40 and 85 years old and have a specific type of PH-COPD diagnosed by a doctor. They should also have stable lung disease and be on optimized COPD treatments. Participants will undergo tests to ensure they meet all the criteria before starting the study. Those who join will receive regular check-ups and assessments throughout the 24-week period to monitor their health and the effect of the treatment. It's important to note that the study is currently recruiting participants, so interested individuals should talk to their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• The key inclusion and exclusion criteria include but are not limited to the following:
• Inclusion Criteria:
• • Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension.
• • Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria.
• • Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening.
• • Has a WHO Functional Class assessment of Class II to IV.
• • If on supplemental oxygen, the regimen must be stable.
• • Has stable and optimized chronic, baseline COPD-specific therapy.
• • If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period.
• • If on antihypertensives and/or a diuretic regimen has stable concomitant use.
• • If on anticoagulants has stable concomitant use.
• • Is of any sex/gender from 40 to 85 years of age inclusive.
• • Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator.
• Exclusion criteria:
• • Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).
• • Has non-COPD related Group 3 PH.
• • Has evidence of untreated more than mild obstructive sleep apnea.
• • Has significant left heart disease.
• • Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period.
• • Has evidence of a resting oxygen saturation (SpO2) \< 88%.
• • Has experienced a moderate or severe COPD exacerbation within 2 months before randomization.
• • Has experienced right heart failure within 2 months before randomization.
• • Has uncontrolled tachyarrhythmia.
• • Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization.
• • Has evidence of significant chronic renal insufficiency.
• • Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities.
• • Initiated a pulmonary rehabilitation program within 2 months before randomization.
• • Has impairments that limit the ability to perform 6MWT.
• • Has history of cancer.
• • Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence.
• • Has used PAH-specific therapies within 2 months of randomization.