Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

December 4, 2023 updated by: Carsten Bindslev-Jensen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in challenge threshold (mg food protein tolerated by oral intake)
Time Frame: 0-3 months
Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo
0-3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))
Time Frame: 0-6 months
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)
Time Frame: 0-6 months
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)
Time Frame: 0-6 months
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))
Time Frame: 0-6 months
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))
Time Frame: 0-6 months
To estimate changes in serum markers for allergy during the treatment
0-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carsten Bindslev-Jensen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis Pharmaceuticals
Thermo Fisher Scientific, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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