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

NCT ID: NCT07027163

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-01

Brief Summary

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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

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Conditions

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Food Hypersensitivity Anaphylaxis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Omalizumab Cohort

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None identified.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CIGE025A2010

Identifier Type: -

Identifier Source: org_study_id

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