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

NCT07027163 | Completed

• 1 other identifier: CIGE025A2010
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Hypersensitivity; Anaphylaxis

Keywords

Food Allergy; IgE-mediated Food Allergy

Outcome Measures

Primary Outcomes (1)

• Number of Patients by Response to Treatment

  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.

  Months 3, 6, 12, and 24

Secondary Outcomes (5)

• Frequency of Accidental Reactions

  Up to approximately 7 years

• Change From Baseline in Allergen Threshold Levels

  From Baseline up to approximately 7 years

• Change From Baseline in Severity of Anaphylactic Reactions

  From Baseline up to approximately 7 years

• 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

• HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)

  Months 3, 6, 12, and 24

Study Arms (1)

Omalizumab Cohort

Adult patients diagnosed with IgE-mediated food allergy who received omalizumab treatment between 2002 and 2022.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• A confirmed history of food allergy, either with or without prior anaphylaxis.
• Treated with omalizumab, either as monotherapy or in combination with OIT.

You may not qualify if:

• None identified.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (1)