A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis

Completed

• Conditions: Food Hypersensitivity; Anaphylaxis

• Registration Number: NCT07027163
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

None identified.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients by Response to Treatment	Months 3, 6, 12, and 24	Patients were classified as treatment responders if an oral food challenge was negative, or a decrease in severity of food allergy during an oral food challenge was determined and no anaphylactic reactions occurred during treatment. Non-responders were those who experienced repetitive food anaphylactic reactions during treatment. Partial treatment responders were patients who experienced less than 1 food anaphylactic reaction despite undergoing treatment.

Secondary Outcome Measures

Name	Time	Method
Frequency of Accidental Reactions	Up to approximately 7 years	Accidental reactions were those that occurred when a patient unknowingly ingested the food allergen.
Change From Baseline in Allergen Threshold Levels	From Baseline up to approximately 7 years	Allergen threshold was measured by oral food challenge test. The change in threshold level means the increase in the food dose that the patient was able to tolerate during the food challenge test.
Change From Baseline in Severity of Anaphylactic Reactions	From Baseline up to approximately 7 years	Change in severity of food allergy was either demonstrated by an oral food challenge or based on the clinical assessment by the investigator.
Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire	Months 3, 6, 12, and 24	The EQ-5D is a generic multidimensional measurement tool for describing HRQoL (EuroQol, 1999). The five domains of mobility, self-care ability, daily activities, pain/discomfort and anxiety/depression are considered. For each of the dimensions, the most appropriate answer from three given possibilities is selected (1=no problem, 2=moderate problem, 3=large problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health). HRQoL was measured if data was available.
HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)	Months 3, 6, 12, and 24	FAQLQs are disease-specific questionnaires used to measure the impact of food allergy on HRQoL. The forms are completed by the patients themselves or by the parents of food-allergic children and teenagers. Questions are scored on a 7-point scale from 1 (no) to 7 (maximal) impairment on quality of life. HRQoL was measured if data was available.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States