Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||6 Years - 25 Years|
Inclusion criteria:1. Male or female subjects 6 to 25 years old at screening visit. 2. History of IgE-mediated allergy to at least three foods within the following list: peanut, milk, egg, wheat, oat, soy, barley, rye, buckwheat, hazelnut, pecan, cashew, pistachio, almond, walnut and sesame. 3. Subjects currently following a strict avoidance of these three foods. 4. Positive SPT with a largest wheal diameter ≥ 6 mm to all three foods. 5. Food-specific IgE level greater than 15 kU/L for all three foods. 6. Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein. 7. Signed informed consent and assent. Exclusion criteria. 1. Subjects reacting objectively to the placebo during the screening DBPCFC. 2. Severe asthma as defined by GINA 201948. 3. Active or past confirmed eosinophilic oesophagitis. 4. Subject currently under allergen immunotherapy. 5. Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion. 6. Subject/parent unwillingness to comply with study requirements. 7. Subject unwillingness to ingest a daily food dose of up to 1500 mg of allergen protein. 8. Inability to discontinue anti-histamine medication prior to study procedures. 9. Known allergy to omalizumab or its excipients. 10. Known allergy to components of the placebo food treatment mix that cannot be substituted without interfering with the blind (e.g.: dates, banana, chocolate syrup) 11. Use of immunosuppression or immunomodulatory drug (including omalizumab) or food oral immunotherapy or investigational treatment or procedure within 1 year. 12. Relative contraindication or inability to use epinephrine auto-injector. 13. Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors. 14. Pregnancy or lactation for the duration of the study. 15. Any condition that is not compatible with the study treatment or procedures as per investigator judgment.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Philippe Bégin, MD, PhD|
|Principal Investigator Affiliation||St. Justine's Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Food IgE-mediated Allergy, Immunotherapy, Omalizumab, Physiological Effects of Drugs|
This is a phase 2b, multi-center randomized controlled trial comparing 2 doses of omalizumab to placebo in subjects 6 to 25 years old with multiple food allergies undergoing a symptom-driven multi-food OIT protocol. Subjects will undergo a screening period involving a DBPCFC to a mix of three allergens which will determine their eligibility and eliciting dose. Eligible subjects will be randomized to one of 2 omalizumab dosages or placebo at a ratio of 2:2:1 for a total period of 20 weeks. They will undergo initial food escalation (IFE) to determine their starting food treatment mix dose for three simultaneous food allergens after a pre-treatment period of 8 weeks with the study drug. Subjects will undergo up-dosing OIT visits at the clinic every two weeks, until a maintenance dose of 1500mg of protein (500mg per food) is reached (primary endpoint).
Experimental: Omalizumab 16 mg/kg
Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Experimental: Omalizumab 8 mg/kg
Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Placebo Comparator: Placebo
Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Biological: - Omalizumab 16mg/kg
Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Biological: - Omalizumab 8mg/kg
Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Biological: - Placebo
Participants will receive placebo for 8 weeks prior to the initiation of oral immunotherapy and 12 weeks after for a total of 20 weeks including a taper period.
Other: - Multi-food oral immunotherapy (OIT)
Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
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.