Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Treatment With Omalizumab in Food Allergic Children (TOFAC)

Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Drug: Omalizumab; Other: Placebo

Detailed Description

Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on children with food allergy.

Primary endpoint: Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo.

Secondary endpoints: Change in challenge threshold at 6 months. Change in Skin Prick Test (SPT), serum markers for allergy (specific IgE, IgG4, BAT (basofil activation test)), severity of comorbidity, and quality of life from at 3 and 6 months. Change in treshold within and between the groups.

The investigator's 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.

Patients are randomized electronically via an e-CRF prepared by OPEN in RedCap. Assigned 3:1 to Omalizumab or placebo in 13 x 8 block (6:2) by a blinded health care person.

GCP-monitoring is performed by the local GCP-unit at Odense University Hospital

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Funen
    • Odense C, Funen, Denmark, 5000
      • Odense Research Center for Anaphylaxis, Allergy Center, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• children between 6 and 18 years
• a clinical diagnosis of food allergy to ≥1 food allergen
• a positive SPT (mean wheal diameter > 3 mm)
• s-IgE > 0.35 kIU/l
• 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).
• (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 s-IgE and when available challenge results within the last year) will be used).

Exclusion Criteria:

• t-IgE >1500 kIU/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 properties that cannot be paused during the study
• Ongoing treatment with drugs that may impair safety during food challenge e.g. β-blockers or ACE-inhibitors that cannot be paused during the study
• Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
• Alcohol abuse, abuse of opioids or other drugs in adolescents
• Treated with Omalizumab until ½ years before the study
• 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
• Patients who have reduced liver function or kidney function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omalizumab; Omalizumab is a sterile solution in a prefilled syring for subcutaneous injection. The syrings contains 75 mg or 150 mg omalizumab. 75 patients will have Omalizumab in doses depending of body weight and IgE every 2. or 4. week for 6 month Omalizumab is administered subcutaneously	Drug: Omalizumab; Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE; Other Names: Xolair
Placebo Comparator: Placebo; Placebo contains sodium chloride 0,9 % in a prefilled syring for subcutaneous injection. 25 patients will have placebo depending of the body weight and IgE every 2. or 4. week in 3 month. They will subsequently get Omalizumab for 3 month if nonresponders. Placebo is administered subcutaneously	Other: Placebo; Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE; Other Names: NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in challenge threshold (mg food protein tolerated by oral intake)	Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo	0-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))	To estimate improvement in QoL before and after 3 months and 6 months treatment, using FAQLQ on a seven point scale with one as the best possible score (score 1-7)	0-6 months
Change in skin prick test size (mm)	To estimate changes in skin prick test size during the treatment	0-6 months
Change in severity of co-morbidity (atopic dermatitis, asthma, allergic rhintitis using clinical severity scores)	To estimate improvement in atopic diseases by evaluation of disease severity (SCORAD atopic dermatitis, VAS and CSMS rhinitis, ATC asthma)	0-6 months
Change in levels of serum markers for food allergy (IgE (kIU/L), IgG4 (kIU))	To estimate changes in serum markers for allergy during the treatment	0-6 months
Change in levels of serum markers for food allergy BAT test (CD-sens))	To estimate changes in serum markers for allergy during the treatment	0-6 months

Collaborators and Investigators

• Sponsor: Carsten Bindslev-Jensen
• Collaborators: Novartis Pharmaceuticals; Thermo Fisher Scientific, Inc
• Investigators: Study Director: Carsten Bindslev-Jensen, Prof DM PhD, Odense Research Center for Anaphylaxis; Study Chair: Susanne Halken, Prof DM MD, Department of Childrens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Xolair; Omalizumab
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: EudraCT 2018-004427-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No