Nctid:
NCT06616974
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006976", "term"=>"Hypertension, Pulmonary"}, {"id"=>"D000006973", "term"=>"Hypertension"}, {"id"=>"D000006333", "term"=>"Heart Failure"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M10024", "name"=>"Hypertension", "asFound"=>"Hypertension", "relevance"=>"HIGH"}, {"id"=>"M9421", "name"=>"Heart Failure", "asFound"=>"Heart Failure", "relevance"=>"HIGH"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M10027", "name"=>"Hypertension, Pulmonary", "asFound"=>"Pulmonary Hypertension", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>180}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-11-20", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change from baseline on mean Pulmonary Vascular Resistance (PVR) in participants with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF)", "timeFrame"=>"Baseline up to Week 24 post first dose", "description"=>"Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo."}, {"measure"=>"Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.", "timeFrame"=>"Baseline up to Week 30 post first dose"}, {"measure"=>"Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.", "timeFrame"=>"Baseline up to Week 30 post first dose"}, {"measure"=>"Number of participants with treatment-related adverse events", "timeFrame"=>"Baseline up to Week 24 post first dose"}, {"measure"=>"Number of participants with changes in the physical examination findings", "timeFrame"=>"Baseline to Week 30 post first dose"}], "secondaryOutcomes"=>[{"measure"=>"Effect of TX000045 on mean PVR in participants with PVR greater than or equal to 3 wood units.", "timeFrame"=>"Baseline to Week 24 post first dose", "description"=>"This is measured by RHC in participants with PVR greater than or equal to 3 wood units."}, {"measure"=>"Mean change from baseline in 6-minute walk test (6MWT) distance.", "timeFrame"=>"Baseline to Week 24 post first dose", "description"=>"To evaluate the effect of TX000045 on exercise capacity in participants with PH-HFpEF those who have received TX000045 and placebo."}, {"measure"=>"Mean change from baseline in 6-minute walk test (6MWT) distance in participants with PVR greater than or equal to 3 wood units.", "timeFrame"=>"Baseline to Week 30 post first dose", "description"=>"To evaluate the effect of TX000045 on exercise capacity in participants with PVR greater than or equal to 3 wood units those who have received TX000045 and placebo."}, {"measure"=>"Change from baseline in Pulmonary capillary wedge pressure (PCWP) in patients who received TX000045 vs Placebo.", "timeFrame"=>"Baseline to Week 24 post first dose", "description"=>"To evaluate the effect on TX000045 vs Placebo on pulmonary capillary wedge pressure (PCWP) in participants with PH-HFpEF."}, {"measure"=>"Change from baseline in mean pulmonary arterial pressure (mPAP) in participants who received TX000045 vs Placebo.", "timeFrame"=>"Baseline to Week 24 post first dose", "description"=>"To evaluate the effect of TX000045 vs Placebo on mPAP in participants with PH-HFpEF."}, {"measure"=>"Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) in participants with PH-HFpEF.", "timeFrame"=>"Baseline to Week 30 post first dose", "description"=>"To evaluate the effect of TX000045 vs. Placebo on NT-proBNP levels."}, {"measure"=>"Change from baseline responses on the Kansas City Cardiomyopathy Questionnaire (KCCQ) in participants with PH-HFpEF.", "timeFrame"=>"Baseline to Week 24 post first dose", "description"=>"To evaluate the effect of TX000045 vs. Placebo on KCCQ scores"}, {"measure"=>"Evaluate the serum concentrations of TX000045", "timeFrame"=>"Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose"}, {"measure"=>"Evaluate immunogenicity of TX000045 by antibody titers", "timeFrame"=>"Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pulmonary Hypertension", "Heart Failure With Preserved Ejection Fraction"]}, "descriptionModule"=>{"briefSummary"=>"TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).", "detailedDescription"=>"This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms:\n\n* Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks\n* Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks\n* Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Is a male or female of non-childbearing potential between the ages of 18 and 80 years.\n2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).\n3. Has NYHA functional class II- III heart failure.\n4. Has 6MWT distance from 100 to 450m.\n5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.\n6. Is able to understand and provide documented consent for participation.\n\nExclusion Criteria:\n\n1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.\n2. Current or recent hospitalization prior to screening.\n3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or relaxin receptor agonist.\n4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.\n5. Has a body mass index \\<18 kg/meter square or \\>45 kg/ meter square.\n6. Was previously administered TX000045, relaxin, or a relaxin fusion protein.\n7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.\n8. Has any of the following clinical laboratory values during screening:\n\n 1. Serum alanine aminotransferase or aspartate aminotransferase levels \\> 3 x the upper limit of normal (ULN) or total bilirubin \\> 3 x ULN;\n 2. eGFR \\<30 mL/min/1.73 metersquare;\n 3. HbA1c (glycosylated hemoglobin) \\>9%;\n 4. Platelet count \\<50,000/millimeter cube;\n 5. Hemoglobin \\<10.0g/dL;\n9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.\n10. Is pregnant or breastfeeding.\n11. Has a history of cancer other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.\n12. Has a history of drug or alcohol abuse.\n13. Was recently dosed in any clinical research study."}, "identificationModule"=>{"nctId"=>"NCT06616974", "briefTitle"=>"A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Tectonic Therapeutic"}, "officialTitle"=>"A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)", "orgStudyIdInfo"=>{"id"=>"TX000045-003"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"TX000045 Dose A", "description"=>"Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.", "interventionNames"=>["Drug: TX000045- Dose A"]}, {"type"=>"EXPERIMENTAL", "label"=>"TX000045 Dose B", "description"=>"Participants will receive alternating single doses of TX000045 Dose B and placebo subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.", "interventionNames"=>["Drug: TX000045- Dose B"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"TX000045- Dose A", "type"=>"DRUG", "description"=>"The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.", "armGroupLabels"=>["TX000045 Dose A"]}, {"name"=>"TX000045- Dose B", "type"=>"DRUG", "description"=>"The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.", "armGroupLabels"=>["TX000045 Dose B"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35205", "city"=>"Birmingham", "state"=>"Alabama", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Birmingham", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"80045", "city"=>"Aurora", "state"=>"Colorado", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Aurora", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"zip"=>"70433", "city"=>"Covington", "state"=>"Georgia", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Covington", "geoPoint"=>{"lat"=>33.59678, "lon"=>-83.86018}}, {"zip"=>"02180", "city"=>"Boston", "state"=>"Massachusetts", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Boston", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"39216", "city"=>"Jackson", "state"=>"Mississippi", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Jackson", "geoPoint"=>{"lat"=>32.29876, "lon"=>-90.18481}}, {"zip"=>"63110", "city"=>"Saint Louis", "state"=>"Missouri", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"St Louis", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"New York", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Durham", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"43606", "city"=>"Toledo", "state"=>"Ohio", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Toledo", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}, {"zip"=>"15213", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Pittsburgh", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"zip"=>"17403", "city"=>"York", "state"=>"Pennsylvania", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"York", "geoPoint"=>{"lat"=>39.9626, "lon"=>-76.72774}}, {"zip"=>"37205", "city"=>"Nashville", "state"=>"Tennessee", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Nashville", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"77702", "city"=>"Beaumont", "state"=>"Texas", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Beaumont", "geoPoint"=>{"lat"=>30.08605, "lon"=>-94.10185}}, {"zip"=>"77642", "city"=>"Port Arthur", "state"=>"Texas", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Port Arthur", "geoPoint"=>{"lat"=>29.88519, "lon"=>-93.94233}}, {"zip"=>"0006", "city"=>"Yerevan", "status"=>"NOT_YET_RECRUITING", "country"=>"Armenia", "facility"=>"Yerevan", 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"city"=>"Chermside", "state"=>"Queensland", "status"=>"NOT_YET_RECRUITING", "country"=>"Australia", "facility"=>"Chermside", "geoPoint"=>{"lat"=>-27.38472, "lon"=>153.03062}}, {"zip"=>"7000", "city"=>"Hobart", "state"=>"Tasmania", "status"=>"NOT_YET_RECRUITING", "country"=>"Australia", "facility"=>"Hobart", "geoPoint"=>{"lat"=>-42.87936, "lon"=>147.32941}}, {"zip"=>"5800", "city"=>"Pleven", "status"=>"NOT_YET_RECRUITING", "country"=>"Bulgaria", "facility"=>"Pleven", "geoPoint"=>{"lat"=>43.41667, "lon"=>24.61667}}, {"zip"=>"4004", "city"=>"Plovdiv", "status"=>"NOT_YET_RECRUITING", "country"=>"Bulgaria", "facility"=>"Plovdiv", "geoPoint"=>{"lat"=>42.15, "lon"=>24.75}}, {"zip"=>"1700", "city"=>"Sofia", "status"=>"NOT_YET_RECRUITING", "country"=>"Bulgaria", "facility"=>"Sofia", "geoPoint"=>{"lat"=>42.69751, "lon"=>23.32415}}, {"zip"=>"1750", "city"=>"Sofia", "status"=>"NOT_YET_RECRUITING", "country"=>"Bulgaria", "facility"=>"Sofia", "geoPoint"=>{"lat"=>42.69751, "lon"=>23.32415}}, {"zip"=>"0186", "city"=>"Tbilisi", "state"=>"Tb", "status"=>"NOT_YET_RECRUITING", "country"=>"Georgia", "facility"=>"Tbilisi", "geoPoint"=>{"lat"=>41.69411, "lon"=>44.83368}}, {"zip"=>"167", "city"=>"Tbilisi", "status"=>"NOT_YET_RECRUITING", "country"=>"Georgia", "facility"=>"Tbilisi", "geoPoint"=>{"lat"=>41.69411, "lon"=>44.83368}}, {"zip"=>"20246", "city"=>"Hamburg", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "facility"=>"Hamburg", "geoPoint"=>{"lat"=>53.57532, "lon"=>10.01534}}, {"zip"=>"55131", "city"=>"Mainz", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "facility"=>"Mainz", "geoPoint"=>{"lat"=>49.98419, "lon"=>8.2791}}, {"zip"=>"42859", "city"=>"Remscheid", "status"=>"NOT_YET_RECRUITING", "country"=>"Germany", "facility"=>"Remscheid", "geoPoint"=>{"lat"=>51.17983, "lon"=>7.1925}}, {"city"=>"Chisinau", "status"=>"RECRUITING", "country"=>"Moldova, Republic of", "facility"=>"Chisinau", "geoPoint"=>{"lat"=>47.00556, "lon"=>28.8575}}, {"zip"=>"8011", "city"=>"Christchurch", "status"=>"NOT_YET_RECRUITING", "country"=>"New Zealand", "facility"=>"Christchurch", "geoPoint"=>{"lat"=>-43.53333, "lon"=>172.63333}}, {"zip"=>"15-276", "city"=>"Białystok", "status"=>"NOT_YET_RECRUITING", "country"=>"Poland", "facility"=>"Białystok", "geoPoint"=>{"lat"=>53.13333, "lon"=>23.16433}}, {"zip"=>"31-202", "city"=>"Kraków", "status"=>"NOT_YET_RECRUITING", "country"=>"Poland", "facility"=>"Krakow", "geoPoint"=>{"lat"=>50.06143, "lon"=>19.93658}}, {"zip"=>"20-090", "city"=>"Lublin", "status"=>"NOT_YET_RECRUITING", "country"=>"Poland", "facility"=>"Lublin", "geoPoint"=>{"lat"=>51.25, "lon"=>22.56667}}, {"zip"=>"91-347", "city"=>"Łódź", "status"=>"NOT_YET_RECRUITING", "country"=>"Poland", "facility"=>"Łodź", "geoPoint"=>{"lat"=>51.75, "lon"=>19.46667}}, {"zip"=>"8035", "city"=>"Barcelona", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "facility"=>"Barcelona", "geoPoint"=>{"lat"=>41.38879, "lon"=>2.15899}}, {"zip"=>"28034", "city"=>"Madrid", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "facility"=>"Madrid", "geoPoint"=>{"lat"=>40.4165, "lon"=>-3.70256}}, {"zip"=>"15706", "city"=>"Santiago De Compostela", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "facility"=>"Santiago de Compostela ( Coruña )", "geoPoint"=>{"lat"=>42.88052, "lon"=>-8.54569}}, {"zip"=>"46010", "city"=>"Valencia", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "facility"=>"Valencia", "geoPoint"=>{"lat"=>39.46975, "lon"=>-0.37739}}, {"zip"=>"27310", "city"=>"Gaziantep", "status"=>"NOT_YET_RECRUITING", "country"=>"Turkey", "facility"=>"Gaziantep", "geoPoint"=>{"lat"=>37.05944, "lon"=>37.3825}}, {"zip"=>"34899", "city"=>"Istanbul", "status"=>"NOT_YET_RECRUITING", "country"=>"Turkey", "facility"=>"Istanbul", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}], "centralContacts"=>[{"name"=>"Clinical Trials", "role"=>"CONTACT", "email"=>"ClinicalTrials@tectonictx.com", "phone"=>"+1 339 337 4053"}], "overallOfficials"=>[{"name"=>"Marcie Ruddy, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Tectonic Therapeutic"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tectonic Therapeutic", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
