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Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Primary Purpose

Food Allergy

Status

Recruiting

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Omalizumab

Placebo

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring Omalizumab, Xolair

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Odense Research Center for Anaphylaxis, Allergy Center, Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omalizumab

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Change in skin prick test size (mm)

To estimate changes in skin prick test size during the treatment

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)

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

Change in levels of serum markers for food allergy BAT test (CD-sens))

To estimate changes in serum markers for allergy during the treatment

Full Information

NCT ID

NCT04037176

First Posted

May 10, 2019

Last Updated

September 20, 2022

Sponsor

Carsten Bindslev-Jensen

Collaborators

Novartis Pharmaceuticals, Thermo Fisher Scientific, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04037176

Brief Title

Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Official Title

Treatment With Omalizumab in Food Allergic Children (TOFAC)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Carsten Bindslev-Jensen

Collaborators

Novartis Pharmaceuticals, Thermo Fisher Scientific, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy

Keywords

Omalizumab, Xolair

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Eligible participants will be randomized to treatment with Omalizumab (regular dose of asthma dosing according to total IgE and weight) or placebo (3:1). Primary endpoint after 3 months treatment. Responders (in the active as well as the placebo group) will continue treatment with the same dose of Omalizumab/placebo for a further 3 months. All non-responders will receive maximum dose of Omalizumab (according to weight, but not total IgE) for another 3 months.

Masking

ParticipantCare ProviderInvestigator

Masking Description

The syringes are filled and masked with opaque material of unblinded personnel who do not have patient contact.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omalizumab

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair

Intervention Description

Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

NaCl

Intervention Description

Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE

Primary Outcome Measure Information:

Title

Change in challenge threshold (mg food protein tolerated by oral intake)

Description

Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo

Time Frame

0-3 months

Secondary Outcome Measure Information:

Title

Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))

Description

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)

Time Frame

0-6 months

Title

Change in skin prick test size (mm)

Description

To estimate changes in skin prick test size during the treatment

Time Frame

0-6 months

Title

Change in severity of co-morbidity (atopic dermatitis, asthma, allergic rhintitis using clinical severity scores)

Description

To estimate improvement in atopic diseases by evaluation of disease severity (SCORAD atopic dermatitis, VAS and CSMS rhinitis, ATC asthma)

Time Frame

0-6 months

Title

Change in levels of serum markers for food allergy (IgE (kIU/L), IgG4 (kIU))

Description

To estimate changes in serum markers for allergy during the treatment

Time Frame

0-6 months

Title

Change in levels of serum markers for food allergy BAT test (CD-sens))

Description

To estimate changes in serum markers for allergy during the treatment

Time Frame

0-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charlotte G. Moertz, Prof PhD MD

Phone

+45 65415025

charlotte.mortz@rsyd.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Henrik F. Kjaer, PhD MD

Phone

+45 65413246

henrik.kjaer@rsyd.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carsten Bindslev-Jensen, Prof DM PhD

Organizational Affiliation

Odense Research Center For Anaphylaxis

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Susanne Halken, Prof DM MD

Organizational Affiliation

Department of Childrens Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Odense Research Center for Anaphylaxis, Allergy Center, Odense University Hospital

City

Odense C

State/Province

Funen

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlotte G. Moertz, ProfMDPhd

Phone

+45 65415025

charlotte.mortz@rsyd.dk

12. IPD Sharing Statement

Learn more about this trial

Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

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