Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status: Unknown

Conditions: Immunotherapy; Bee Venom; Allergy; Omalizumab

Treatments: Drug: omalizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02968394

NEVIT

Details and patient eligibility

About

The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.

Full description

Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.

Enrollment: 11 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
• honey-bee venom immunotherapy treatment failure due to systemic reactions.

Exclusion criteria

• systemic mastocytosis,
• pregnancy,
• use of beta-adrenergic blocking agents.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

NEVIT

Experimental group

Description:

Co treatment with omalizumab during another attempt of immunotherapy introduction

Treatment:

Drug: omalizumab