Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

NCT04037176 | Completed Phase 4 DMC

• 1 other identifier: EudraCT 2018-004427-37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Omalizumab; Xolair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  0-6 months

• Change in skin prick test size (mm)

  0-6 months

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

  0-6 months

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

  0-6 months

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

  0-6 months

Study Arms (2)

Omalizumab

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Omalizumab DRUG

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

Also known as: Xolair

Omalizumab

Placebo OTHER

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

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Carsten Bindslev-Jensen: lead
• Novartis Pharmaceuticals: collaborator
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (1)

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

Odense C, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Carsten Bindslev-Jensen, Prof DM PhD

  Odense Research Center For Anaphylaxis

  STUDY DIRECTOR

• Susanne Halken, Prof DM MD

  Department of Childrens Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The syringes are filled and masked with opaque material of unblinded personnel who do not have patient contact.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, M.D., Dr.Med. Ph.D,

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: July 30, 2019
• Study Start: November 1, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

DK (1)