[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588602":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":91,"collaborators":41,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":41,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":45,"whyStopped":41,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients Receiving 5mg\u002Fkg of omalizumab","ACTIVE_COMPARATOR","Participants randomized to this arm will receive a does of 5mg\u002Fkg Omalizumab per month divided every two (2) weeks for 16 weeks.",[13],"Drug: 5mg\u002Fkg omalizumab injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients Receiving 15mg\u002Fkg of omalizumab","Participants randomized to this arm will receive a does of 15mg\u002Fkg Omalizumab per month divided every two (2) weeks for 16 weeks.",[18],"Drug: 15mg\u002Fkg omalizumab injection",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","5mg\u002Fkg omalizumab injection","5mg\u002Fkg of omalizumab",[9],[26],"Xolair",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"15mg\u002Fkg omalizumab injection","15mg\u002Fkg of omalizumab",[15],[26],[33],{"name":34,"affiliation":5,"role":35},"Wayne Shreffler, MD, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Jannat Gill","CONTACT","617-643-8683",null,"Jgill@mgh.harvard.edu",[44,63,77],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,61],{"name":38,"role":39,"phone":59,"phoneExt":41,"email":60},"614-643-8683","Jgill0@mgh.harvard.edu",{"name":62,"role":35,"phone":41,"phoneExt":41,"email":41},"Wayne Shreffler, MD",{"facility":64,"status":45,"city":65,"state":66,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":52,"coordinates":69},[70,71],-79.05584,35.9132,{"lat":71,"lon":70},[74],{"name":75,"role":39,"phone":41,"phoneExt":41,"email":76},"Lauren Herlihy","lherlihy@unc.edu",{"facility":78,"status":45,"city":79,"state":80,"zip":81,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University of Texas Southwestern","Dallas","Texas","75390",{"type":52,"coordinates":83},[84,85],-96.80667,32.78306,{"lat":85,"lon":84},[88],{"name":89,"role":39,"phone":41,"phoneExt":41,"email":90},"Dolores Santoyo","Dolores.Santoyo@UTSouthwestern.edu",{"type":35,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Wayne G. Shreffler, MD, PhD","Principal Investigator","100588602","phase-2-omalizumab-weight-based-dosing-efficacy-trial-100588602",false,"NCT06943534","Omalizumab Weight-Based Dosing Efficacy Trial","OWED-T","Inclusion Criteria:\n\n* A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk)\n* Positive food specific IgE (≥2.0 kUA\u002FL) to at least two of the relevant foods\n* A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food\n\n(If meeting above criteria):\n\n* Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)\n\nExclusion Criteria:\n\n* Weight \\>80 kg at time of screening\n* Clinically significant laboratory abnormalities at screening.\n* Sensitivity or suspected\u002Fknown allergy to any ingredients (including excipients) of omalizumab.\n* Poorly controlled or severe asthma\u002Fwheezing at screening\n* History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation.\n* Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma\u002Fwheezing within 30 days of screening.\n* Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.\n* Past or current history of eosinophilic gastrointestinal disease within three years of screening.\n* Past or current history of cancer, or currently being investigated for possible cancer.\n* Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening.\n* Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening.\n* Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs.\n* Pregnant or breastfeeding or intending to become pregnant during the study.\n* Evidence of clinically significant chronic disease.","ALL","1 Year","55 Years",{"count":105,"type":106},30,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.",[112,113],"Allergies","Food Allergy",[115],"omalizumab","2026-02-03",{"date":118,"type":119},"2026-02-05","ACTUAL",{"date":121,"type":119},"2025-07-03",{"date":123,"type":106},"2028-04-01",{"name":5,"class":6},3]