[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DBV Technologies\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100593244","phase-3-safety-study-of-viaskin-peanut-patch-in-peanut-allergic-children-1-through-3-years-of-age-comfort-toddlers-100593244",false,"NCT07003919","Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)","A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy","Key Inclusion Criteria:\n\n* Aged 1 through 3 years at Visit 1 (screening).\n* Physician-diagnosed peanut allergy and following a strict peanut-free diet\n* Peanut-specific IgE \\> 0.7 kUA\u002FL.\n* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).\n* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).\n\nKey Exclusion Criteria:\n\n* Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.\n* Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).\n* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and\u002For insect allergy).\n* History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).\n* Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.\n* Uncontrolled persistent asthma.","ALL","1 Year","3 Years",{"count":20,"type":21},480,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.",[27,28],"Allergy","Peanut Allergy",[30,31,32,33,34,35,36,28,37,38,39],"Peanut hypersensitivity","Epicutaneous Immunotherapy (EPIT)","Epicutaneous","Immunotherapy","Viaskin","Nut and Peanut Hypersensitivity","Food Hypersensitivity","Food Allergy","Nut and Peanut Allergy","Safety Study","RECRUITING","2026-06-17",{"date":43,"type":44},"2026-06-18","ACTUAL",{"date":46,"type":44},"2025-06-24",{"date":48,"type":21},"2028-05",{"name":50,"class":51},"DBV Technologies","INDUSTRY",91,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":61,"enrollmentInfo":4,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":71,"locationsCount":72},"100471888","expanded-access-protocol-of-viaskin-peanut-dbv712-in-peanut-allergic-children-100471888","NCT05424731","Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children","Viaskin® Peanut (DBV712) Compassionate Use in Peanut-allergic Children Previously Enrolled in a DBV712 Clinical Study","Inclusion Criteria:\n\n* Participation is by invitation, limited to individuals completing clinical study V712-303 (PEOPLE), previous Expanded Access Program or a DBV clinical study initiated after 31-Jan-2022\n* Male and females; ages ≥ 2 years old at Visit 1 or current or prior studies.\n* Negative urine pregnancy test for female participants of childbearing potential.\n\nExclusion Criteria:\n\n* Early withdrawal from a DBV712 clinical study.\n* History of non-compliance during the primary clinical study or unable to follow the protocol requirements.\n* Generalized dermatologic disease extending widely on the skin.\n* History of intolerance or who developed hypersensitivity to excipients of the DBV712 patches.","2 Years","17 Years","EXPANDED_ACCESS","This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.",[28],[66,32,33,34],"EPIT","AVAILABLE","2026-01-14",{"date":70,"type":44},"2026-01-15",{"name":50,"class":51},1,""]