Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

NCT ID: NCT04037176

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-03-15

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

Conditions

Food Allergy

Keywords

Omalizumab; Xolair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Omalizumab

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Xolair; NaCl

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).

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role: collaborator

Carsten Bindslev-Jensen

OTHER

Sponsor Role: lead

Responsible Party

Carsten Bindslev-Jensen

Professor, M.D., Dr.Med. Ph.D,

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carsten Bindslev-Jensen, Prof DM PhD

Role: STUDY_DIRECTOR

Odense Research Center For Anaphylaxis

Susanne Halken, Prof DM MD

Role: STUDY_CHAIR

Department of Childrens Hospital

Locations

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

Odense C, Funen, Denmark

Countries

Denmark

Other Identifiers

EudraCT 2018-004427-37

Identifier Type: -

Identifier Source: org_study_id