Study analyzing the efficacy and safety of low-dose oral immunotherapy in children with severe allergy to cow's milk treated with Omalizumab. ILO study

You likely can't join if

• 1. Use of other investigational drugs within 5 half-lives or 30 days prior to Screening Visit 1 (whichever is longer). 2. History of allergy to omalizumab or its excipients. 3. Allergy to any of the components of the matrix used for the double-blind placebo-controlled oral challenge trial (PODCCP) with milk. 4. Inability to complete study procedures and follow-up. 5. Subjects having a combination of weight and IgE that requires Omalizumab doses greater than 1,200 mg/4 weeks. 6. History of life-threatening allergic reaction after ingestion of milk that required admission to the Intensive Care Unit in the 60 days prior to the Screening Visit. 7. Participants with uncontrolled asthma (according to GINA, GINA 2022 guidelines) who meet any of the following criteria: a. FEV1 < 80% predicted at Screening Visit 1. b. One hospitalization for asthma in the 12 months prior to Screening Visit 1. 8. Patients with severe persistent asthma who require continued treatment with omalizumab. 9. History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, symptoms of dysphagia (eg, difficulty swallowing), recurrent gastrointestinal symptoms of undiagnosed etiology, or meeting clinical criteria for cow's milk protein-induced enterocolitis (FPIES) . 10. Current or past history of mast cell disorders, including mastocytosis. 11. Use of prohibited medication or medication not permitted under certain conditions. 12. Participants with evidence of parasitic helminthic infestation to a pathogenic organism evidenced by stool study at Screening Visit 1. 13. History of malignancy in the previous 5 years. 14. Clinically significant cardiovascular diseases. 15. Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or calcium channel blockers. 16. Neurological, psychiatric or metabolic diseases that may interfere or compromise the safety of patients or the evaluation, interpretation of study results or prevent completion of the study. 17. History of, or current treatment for, liver disease or serum transaminase levels 1.5 times the upper limit of normal at Screening Visit 1. 18. History of renal disease or serum creatinine levels 1.5 times the upper limit of normal at Screening Visit 1. 19. Platelets < 100,000/µL at Screening Visit 1. 20. Current participation in any other intervention study. 21. Subject is in dose escalation (dose escalation) phase of immunotherapy for another allergen (has not reached maintenance dose). 22. Pregnancy or lactation.