Omalizumab in Severe Asthmatics With Food Allergy

NCT06316414 | Completed FDA Drug

• 1 other identifier: 1501/17
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment.

Conditions

Food; Allergy, Anaphylactic Shock; Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.

  Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food

  Four months (T1)

Secondary Outcomes (9)

• Proportion of negative OFCs at T1

  Four months (T1)

• NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.

  Eight months (T2)

• NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.

  Twelve months (T3)

• Change in number of anaphylactic events

  Twelve months (T3)

• Rate of severity of anaphylactic events

  Twelve months (T3)

Study Arms (1)

Severe asthmatics with history of food anaphylaxis

Omalizumab will be administered i.m. with doses ranging from 150 mg every 28 days to 600 mg every 14 days, according to EMA dosing range table.

Biological: Omalizumab

Interventions

Omalizumab BIOLOGICAL

Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.

Severe asthmatics with history of food anaphylaxis

Eligibility Criteria

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

Study Population

* Children with severe asthma eligible for treatment with Omalizumab consecutively enrolled at the Bambino Gesu Pediatrica Hospital IRCCS in Rome * ACT \< 20 * Food allergy as described * History of food-induced anaphylaxis * positive OFCs with milk, baked milk, egg, baked egg, wheat, peanut, hazelnut, codfish.

You may qualify if:

• Age 6 - 18 years
• Severe persistent allergic asthma according to the GINA guidelines
• Sensitized to a perennial aeroallergen, as witnessed by positive skin test and/or in vitro reactivity
• Symptoms inadequately controlled with inhaled corticosteroids + another medication, as witnessed by an ACT ≤ 19
• On treatment with high dose inhaled corticosteroids + another medication. Threshold dose for inhaled corticosteroids set at 400 mcg/day budesonide (or equivalent doses) for children \< 12 years, at 800 mcg/day for older patients.
• Immediate food allergy with anaphylactic symptoms within 1hr. of ingestion of milk, egg, wheat, peanut, hazelnut, and/or codfish.
• Total IgE \< 70 and \>1,500 kU/L at baseline
• Sensitivity to food allergen documented by a positive skin prick test result and/or allergen-specific IgE level, with 0.35 kU/L as a lower limit of eligibility
• Positive OFC within the past 12 months, with minimal or no reactions to the placebo challenge.
• Trained on the proper use of epinephrine
• In case of female subjects of child-bearing potential, negative human chorionic gonadotropin blood sample for pregnancy testing
• No known contraindications to oral immunotherapy with food protein or Omalizumab
• Parent/legal guardian written informed consent

You may not qualify if:

• Total IgE at screening \> 70 or ≤ 2,500 kUI/L
• allergy to food(s) not investigated in this study
• Immune deficiency
• Previous reaction to Omalizumab
• Previous organ transplantation
• Use of monoclonal antibodies in the previous 6 months
• Subjects with gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease.
• Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study
• Pregnant or breast-feeding females.
• Subjects with food protein induced enterocolitis syndrome (FPIES)
• Subjects is on a build-up phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose)
• Inability to discontinue antihistamines for 5 half-lives prior to routine study tests (OFC)
• Subjects with weight-IgE combination yielding a dose requirement greater than 600 mg according to the EMA schedule for Omalizumab
• Systemic steroids oral, IM, or IV for indications other than asthma for more than 3 weeks in the past 6 months.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt

Roma, 00145, Italy

Location

Related Publications (3)

• Fiocchi A, Artesani MC, Riccardi C, Mennini M, Pecora V, Fierro V, Calandrelli V, Dahdah L, Valluzzi RL. Impact of Omalizumab on Food Allergy in Patients Treated for Asthma: A Real-Life Study. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1901-1909.e5. doi: 10.1016/j.jaip.2019.01.023. Epub 2019 Feb 20.

  PMID: 30797778 BACKGROUND

• Arasi S, Bitetti C, Lo Scalzo L, Spagnoli A, Fabrizi E, Fiocchi A, Cafarotti A. Omalizumab Dose-Related Efficacy in a Cohort of Children With Severe Food Allergy: OSAFA Observational Study. Allergy. 2026 Jan 19. doi: 10.1111/all.70228. Online ahead of print.

  PMID: 41555682 DERIVED

• Arasi S, Cafarotti A, Galletta F, Panetta V, Riccardi C, Calandrelli V, Fierro V, Dahdah L, Artesani MC, Valluzzi RL, Pecora V, Tallarico V, Dinardo G, Lo Scalzo L, Fiocchi A. Omalizumab reduces anaphylactic reactions and allows food introduction in food-allergic in children with severe asthma: An observational study. Allergy. 2025 Apr;80(4):1074-1085. doi: 10.1111/all.16314. Epub 2024 Sep 16.

  PMID: 39282750 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Anaphylaxis

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact alexfioc@gmail.com

Locations

IT (1)