[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ige-mediated-cow-milk-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ige-mediated-cow-milk-allergy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,69],{"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":30,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100624379","phase-1-a-phase-1-study-of-cizutamig-in-ige-mediated-diseases-100624379",false,"NCT07408869","A Phase 1 Study of Cizutamig in IgE Mediated Diseases","A Phase 1b, Open-Label Study Evaluating the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Cizutamig in IgE Mediated Diseases","Inclusion Criteria:\n\n1. Patient meets at least one of the following:\n\n   1. History of documented (skin prick test, in vitro testing, or food challenge), ongoing, IgE-mediated allergy to food (eg, peanut, hazelnut, walnut, cashew, milk, egg\u002Fegg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and\u002For shrimp) with Screening total IgE ≥ 400 IU\u002FmL\n   2. Diagnosis of chronic rhinosinusitis with Screening total IgE \\> ULN\n   3. Diagnosis of allergic rhinitis with Screening total IgE \\> ULN\n   4. Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE \\> ULN\n   5. Diagnosis of chronic spontaneous urticaria with symptoms (eg, wheals or angioedema) for at least 6 weeks any time prior to screening and Screening total IgE \\> ULN\n   6. Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE \\> ULN\n2. Agree to the use of highly effective contraception\n\nExclusion Criteria:\n\n1. Elevated IgE levels for reasons other than the IgE mediated diseases\n2. Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)\n3. Current use of any allergen immunotherapy.\n4. Individuals whose allergen exposures in their home and\u002For work environments may be expected to change significantly during the trial period\n5. Inadequate clinical laboratory parameters at Screening\n6. Receipt of or inability to discontinue any excluded therapies\n7. Individuals who will decline blood products\n8. Active infection\n9. Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF\n10. Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)\n11. History of primary immunodeficiency\n12. History of CNS disease\n13. History of poorly controlled diabetes, chronic kidney disease, chronic pulmonary disease, uncontrolled cardiovascular disease, history of malignancy within 5 years\n14. History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug\n15. Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period\n16. Blood donation or significant blood loss within 30 days prior to screening\n17. Individuals considered to be part of a vulnerable population (eg, incarceration)\n18. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial\n19. Inability to comply with protocol-mandated requirements\n20. A history of severe allergic or anaphylactic reactions related to the underlying IgE mediated disease","ALL","18 Years","65 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.",[27,28,29],"IgE-Mediated Hypersensitivity","IgE Mediated Food Allergy","IgE-Mediated Cow Milk Allergy",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55],"peanut allergy","nut allergy","hazelnut allergy","walnut allergy","cashew allergy","milk allergy","egg allergy","soy allergy","wheat allergy","sesame allergy","cod allergy","salmon allergy","tuna allergy","lobster allergy","crab allergy","shrimp allergy","food allergy","rhinosinusitis","allergic rhinitis","asthma","urticaria","atopic dermatitis","immune system","cizutamig","T cell engager","NOT_YET_RECRUITING","2026-04-14",{"date":59,"type":60},"2026-04-16","ACTUAL",{"date":62,"type":21},"2026-04",{"date":64,"type":21},"2026-12",{"name":66,"class":67},"Candid Therapeutics","INDUSTRY",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":68},"100608150","evaluation-of-the-tolerance-of-a-new-formula-based-on-hydrolyzed-rice-proteins-in-children-with-cows-milk-allergy-100608150","NCT07197814","Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy","Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy","Inclusion Criteria:\n\n* Infants and young children between 1 and 36 months of age\n* Consuming at least 240 ml\u002Fday of formula\n* Gestational age ≥ 37 weeks\n* Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment\n* Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment\n* Observing a strict cow's milk proteins elimination diet for at least 4 weeks prior to study enrollment\n* Parents or legal guardians agree not to enroll infant in another interventional clinical study while participating in this study\n* Written informed consent form obtained from both parents (or legally acceptable representative \\[LAR\\], if applicable)\n* Infant's parents \u002F LAR are of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.\n* Signed authorization obtained from both parents or legal guardian to use and\u002For disclose Protected Health Information for infant from birth through the length of the study period\n\nExclusion Criteria:\n\n* Infant is exclusively breastfed.\n* Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and\u002For commonly performed diagnostic criteria).\n* Major gastrointestinal disease\u002Fabnormalities (other than CMA).\n* Other food allergies\n* Eosinophilic disorders of the gastrointestinal tract.\n* Evidence of non-IgE-mediated CMA.\n* Immunodeficiency.\n* Use of drugs that may interfere with the interpretation and safety of the SPT procedure planned on Inclusion visit such as antihistamines and topical corticosteroids in the previous week, angiotensin-converting enzyme (ACE) inhibitors within the 2 days before or beta-blockers the day before as well as skin moisturizers used on the skin where solution drops will be applied.\n* Previous use of systemic immunomodulatory treatment at any time before study entry.\n* Use of systemic antibiotics or anti-mycotic drugs within 4 weeks before study entry.\n* Persistent wheeze or chronic respiratory disease.\n* Severe uncontrolled eczema.\n* Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.\n* Infant's parents\u002FLAR have medical or psychiatric condition that, in the judgement of the Investigator, would make the subject inappropriate for entry into the study.","1 Month","36 Months",{"count":79,"type":21},29,[81],"NA","The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered \" hypoallergenic \".\n\nThe main question it aims to answer is: Does the Rice formula cause allergic reactions in infants and young children who are allergic to cow's milk? Researchers will compare during a double-blind placebo-controlled food challenge (DBPCFC) the Rice formula to a Placebo formula to see if any allergic symptom appears after feeding with the Rice formula. If children do not show any allergic symptoms during the DBPCFC, they will then be exclusively formula-fed the Rice formula for 7 days.\n\nParticipants will:\n\n* come at the hospital twice (around 7 days apart) for the DBPCFC\n* then, after this procedure, be fed the Rice formula for 7 days, as a replacement for their usual infant formula\n\nTheir parents will pay attention to the appearance of any allergic symptom after each day of the DBPCFC, and during the 7-day feeding period. They will keep a diary of any adverse event in their child, the use of any concomitant treatment, and the introduction in their child's diet of any new allergenic food. In addition, during the 7-day feeding period, they will report quantities of the Rice formula consumed, data on regurgitations\u002Fvomiting if any, stool consistency\u002Ffrequency\u002Fcolour and their satisfaction.",[29],[85,86,87,88,89,90],"Cow's milk allergy","Hydrolyzed rice proteins-based formula","IgE-mediated","Oral food challenge","Hypoallergenicity","Tolerance","RECRUITING","2026-01-27",{"date":94,"type":60},"2026-01-29",{"date":96,"type":60},"2026-01-23",{"date":98,"type":21},"2026-10",{"name":100,"class":67},"Health and Happiness Research Limited"]