Treatment with Omalizumab in food allergic childre

Phase 1

• Conditions: Food Allergy with Anaphylaxis; MedDRA version: 20.0 Level: LLT Classification code 10064075 Term: Seafood allergy System Organ Class: 100000004870; MedDRA version: 20.0 Level: LLT Classification code 10014315 Term: Egg allergy System Organ Class: 100000004870; MedDRA version: 20.0 Level: LLT Classification code 10016709 Term: Fish allergy System Organ Class: 100000004870; MedDRA version: 20.0 Level: LLT Classification code 10040539 Term: Shellfish allergy System Organ Class: 100000004870; MedDRA version: 20.0 Level: LLT Classification code 10001745 Term: Allergy to cow's milk System Organ Class: 100000004870; MedDRA version: 20.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870; MedDRA version: 20.0 Level: LLT Classification code 10011240 Term: Cow's milk allergy System Organ Class: 100000004870; MedDRA version: MedDRA version: 20.1 Level: LLT Classification code 10054957 Term: Allergy to grains System Organ Class: 100000004870

• Registration Number: EUCTR2018-004427-37-DK
• Lead Sponsor: Odense Research Centre for Anaphylaxis (ORCA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

100 children between 6 and 18 years with a clinical diagnosis of food allergy to =1 food allergen, including a positive skin prick test (SPT) (mean wheal diameter > 3mm), specific IgE (s-IgE) > 0.35 kIU/l to the allergen in question, and a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC) (Table 2). If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of specific IgE and when available challenge results within the last year) will be used.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Total IgE >1500 kU/L
•Significant co-morbidity that might compromise the patient’s safety or study outcomes
•Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken.
•Ongoing treatment with antihistamine or drugs with antihistaminic effect
•Ongoing treatment with ß-blockers and ACE-inhibitors
•Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
•Alcohol abuse, abuse of opioids or other drugs in adolescents
•Patients/parents who are not supposed to be able to meet the requirements in the protocol
•Patients/parents who are physically or mentally unable to consent
•Occurrence of unexpected side effects
•Patients who have reduced liver function or kidney function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 1.To evaluate the efficacy of Omalizumab on food allergy thresholds in children.<br> ;<br> Secondary Objective: 2.To evaluate if skin prick test (SPT), specific IgE (s-IgE), total-IgE (t-IgE), Histamine release (HR) test, Basophil Activation Test (BAT) and specific IgG4 to culprit foods can be used as predictors for the effect of Omalizumab. <br> 3.To evaluate the efficacy of Omalizumab on comorbidity severity and Quality of Life (QoL).<br> ;<br> Primary end point(s): Primary endpoint<br> Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo. <br> <br> ;Timepoint(s) of evaluation of this end point: Not applicable