Treatment with Omalizumab in food allergic children

Treatment with Omalizumab in food allergic children - TOFAC

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004427-37-DK

Enrollment

100

Registered

2019-01-04

Start date

2019-02-20

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Xolair Pharmaceutical Form: Injection INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-4 Other descriptive name: Xolair

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To evaluate the efficacy of Omalizumab on food allergy thresholds in children. ; 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. 3.To evaluate the efficacy of Omalizumab on comorbidity severity and Quality of Life (QoL). ; Primary end point(s): Primary endpoint Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo. ;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: 1.To evaluate the efficacy of Omalizumab on food allergy thresholds in children. ; 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. 3.To evaluate the efficacy of Omalizumab on comorbidity severity and Quality of Life (QoL). ; Primary end point(s): Primary endpoint Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo. ;Timepoint(s) of evaluation of this end point: Not applicable

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints Change in challenge threshold, SPT, specific IgE, IgG4, HR test, BAT, severity of comorbidity, and quality of life at 3 and 6 months and from 0 to 6 months of treatment within and between the groups. Our hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold. Within the groups: •3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in asthma dose – in primary responders •3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment with Omalizumab in max dose – in primary non-responders •3 months treatment with placebo versus 6 months with placebo – in primary placebo-responders •3 months treatment with placebo versus 3 months with max dose Omalizumab – placebo cross over to active Between the groups: •3 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab •6 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab ;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Secondary end point(s): Secondary endpoints Change in challenge threshold, SPT, specific IgE, IgG4, HR test, BAT, severity of comorbidity, and quality of life at 3 and 6 months and from 0 to 6 months of treatment within and between the groups. Our hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold. Within the groups: •3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in asthma dose – in primary responders •3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment with Omalizumab in max dose – in primary non-responders •3 months treatment with placebo versus 6 months with placebo – in primary placebo-responders •3 months treatment with placebo versus 3 months with max dose Omalizumab – placebo cross over to active Between the groups: •3 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab •6 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab ;Timepoint(s) of evaluation of this end point: Not applicable

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Countries

Denmark

Contacts

Public ContactAllergy Center

Odense Research Centre for Anaphylaxis (ORCA)

louise.parke@rsyd.dk0045 65413621

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026