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

Phase 1

• Conditions: Severe IgE-mediated cow's milk allergy; MedDRA version: 20.0Level: HLGTClassification code: 10021505Term: Immunology and allergy investigations Class: 10022891; MedDRA version: 20.0Level: PTClassification code: 10016946Term: Food allergy Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code: 10076438Term: Milk protein allergy Class: 10021428; MedDRA version: 20.0Level: LLTClassification code: 10001745Term: Allergy to cow's milk Class: 10021428; MedDRA version: 20.0Level: LLTClassification code: 10011240Term: Cow's milk allergy Class: 10021428; MedDRA version: 20.0Level: PTClassification code: 10027633Term: Milk allergy Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-503958-12-00
• Lead Sponsor: Hospital Infantil Universitario Nino Jesus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Men and women between the ages of 6 and 15 at the time of signing the consent/assent. 2. Signature of informed consent and/or assent (where applicable), which must be obtained prior to participation in the study. Parents/legal guardians and participants ages 12-15 must be able to understand and provide written consent and assent, respectively. 3. Documented medical history of allergy to milk or foods containing milk. 4. Episodes of anaphylaxis due to ingestion of cow's milk (> 0) and/or the diagnosis of asthma. 5. Serum IgE to cow's milk and casein > 49 kUA/L at Screening Visit 1. 6. Positive skin tests for cow's milk and casein. It is defined as a mean wheal diameter (mean of the sum of the largest and smallest diameters) > 3 mm compared to the negative control. 7. Participants must weigh > 19 kg at Screening Visit 1. 8. Participants must be able to receive injections (study drug), perform oral challenge testing, and must continue to be exposed to cow's milk throughout the study.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified