Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04037176
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Carsten Bindslev-Jensen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carsten Bindslev-Jensen, Prof DM PhDSusanne Halken, Prof DM MD
Principal Investigator Affiliation	Odense Research Center For AnaphylaxisDepartment of Childrens Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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

Arms & Interventions

Arms

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

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

Interventions

Drug: - Omalizumab

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

Other: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Odense C, Funen, Denmark

Status

Recruiting

Address

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

Odense C, Funen, 5000

Site Contact

Charlotte G. Moertz, ProfMDPhd

charlotte.mortz@rsyd.dk

+45 65415025

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