Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT05612035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2022-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-10-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': '6MWD is assessed using the 6-minute walk test (6MWT).'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in 6MWD at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': '6MWD is assessed using the 6-minute walk test (6MWT).'}, {'measure': 'Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'NT-proBNP was measured at baseline and Week 12.'}, {'measure': 'Mean Change From Baseline in NT-ProBNP at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'NT-proBNP was measured at baseline and Week 24'}, {'measure': 'Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.'}, {'measure': 'Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.'}, {'measure': 'Percentage of Participants With One or More Adverse Events (AEs)', 'timeFrame': 'Up to Week 206', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}, {'measure': 'Percentage of Participants who Discontinued Study Treatment due to an AE', 'timeFrame': 'Up to Week 204', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26243&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension.\n* Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria.\n* Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening.\n* Has a WHO Functional Class assessment of Class II to IV.\n* If on supplemental oxygen, the regimen must be stable.\n* Has stable and optimized chronic, baseline COPD-specific therapy.\n* 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.\n* If on antihypertensives and/or a diuretic regimen has stable concomitant use.\n* If on anticoagulants has stable concomitant use.\n* Is of any sex/gender from 40 to 85 years of age inclusive.\n* 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.\n\nExclusion criteria:\n\n* Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).\n* Has non-COPD related Group 3 PH.\n* Has evidence of untreated more than mild obstructive sleep apnea.\n* Has significant left heart disease.\n* Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period.\n* Has evidence of a resting oxygen saturation (SpO2) \\< 88%.\n* Has experienced a moderate or severe COPD exacerbation within 2 months before randomization.\n* Has experienced right heart failure within 2 months before randomization.\n* Has uncontrolled tachyarrhythmia.\n* Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization.\n* Has evidence of significant chronic renal insufficiency.\n* Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities.\n* Initiated a pulmonary rehabilitation program within 2 months before randomization.\n* Has impairments that limit the ability to perform 6MWT.\n* Has history of cancer.\n* Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence.\n* Has used PAH-specific therapies within 2 months of randomization.'}, 'identificationModule': {'nctId': 'NCT05612035', 'briefTitle': 'Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '5475-013'}, 'secondaryIdInfos': [{'id': 'MK-5475-013', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2022-501201-13-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1279-8512', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Frespaciguat', 'description': 'Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period).', 'interventionNames': ['Drug: Frespaciguat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).', 'interventionNames': ['Drug: Frespaciguat', 'Drug: Placebo']}], 'interventions': [{'name': 'Frespaciguat', 'type': 'DRUG', 'otherNames': ['MK-5475'], 'description': 'Frespaciguat 380 µg administered as dry powder inhalation once daily.', 'armGroupLabels': ['Frespaciguat', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered as dry powder inhalation once daily.', 'armGroupLabels': ['Placebo']}]}, 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Corp. 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