Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

National Institute of Allergy and Infectious Diseases (NIAID)458 enrolled

Overview

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Food allergy affects about 15 million people in the United States. This includes 6 million children. The current treatment for food allergy is to avoid eating the foods that may cause an allergic reaction and have medications such as epinephrine (adrenaline) in case of a reaction. However, accidental exposures can be extremely difficult to avoid, particularly if you are allergic to multiple foods. The risks of accidental exposures and life-threatening reactions can place a large burden on patients and their families. Investigators in this study would like to learn if omalizumab injections alone or in combination with multi-allergen oral immunotherapy (OIT) will help people with multiple food allergies eat foods to which they are allergic. Oral means that you will take the food allergen (peanut and 2 other foods to which you are allergic) by mouth. If you are allergic to more than 3 foods, this study will only provide OIT for peanut and 2 other foods. There are 3 stages to the study: In Stage 1, investigators would like to learn: • If omalizumab stops or decreases allergic reactions to peanut and other common food allergens after taking it for a length of time. Stage 1 will also have an extra part so that 60 participants will receive omalizumab and everyone (the investigators conducting the research and study participants) will know it. This is why it is called the open label extension. This part of the study will assist investigators in learning if receiving omalizumab for a longer time may work better at decreasing allergic reactions. In Stage 2, investigators would like to learn: • How a short course of omalizumab combined with Multi-allergen OIT compares with a longer course of omalizumab in decreasing allergic reactions. In Stage 3, investigators would like to learn: • If, after participants stop both treatments, will they be able to eat the peanut and the 2 other foods in the form that is normally eaten. In all stages, investigators would like to learn: * How safe and effective the treatments are and * How the OIT affects the immune system. Participation will last up to 56 months (4 years and 8 months).

Interventions

OmalizumabDRUG

Omalizumab will be supplied in pre-filled syringes (PFS). PFS of omalizumab will be provided to the clinical research units as 75 mg and 150 mg dosage forms.

Placebo for OmalizumabDRUG

Placebo contains the same ingredients as the omalizumab formulation, excluding omalizumab. Placebo will be supplied in pre-filled syringes (PFS). PFS of placebo will be provided to the clinical research units as 75 mg and 150 mg dosage forms.

Multi-Allergen Oral ImmunotherapyDRUG

Multi-allergen OIT will be any of the following drug products: peanut, milk, egg, wheat, cashew, hazelnut, and walnut (all food protein flours). A prescription for each participant for the appropriate dose of each of the allergens will be prepared. The pharmacist will compound the appropriate allergens and dispense the Multi-allergen OIT dose in a blinded (masked) fashion. The Clinical Research Unit (CRU) staff will administer food flour to the participant orally in an age-appropriate food vehicle (e.g., applesauce, pudding, etc.). Dosage will be administered according to the study protocol.

Placebo for Multi-Allergen Oral ImmunotherapyDRUG

Oat flour will be used for placebo for Multi-allergen OIT. Route: by mouth/oral. Dosage will be administered according to the study protocol.

Double-Blind Placebo-Controlled Food Challenge Based TreatmentOTHER

Each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods. A treatment plan will include instructions for one of the following: * Long-term follow-up with dietary consumption of a food; or * Long-term follow-up with avoidance of a food; or * Rescue OIT for a food. The treatment plan for each food may change depending on a participant's response to prescribed treatment over time.

Eligibility

Sex: ALLMin age: 1 YearMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: Individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable; 2. Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study: 1. Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut, 2. Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and 3. Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein. 3. Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study: 1. Positive SPT (≥4 mm wheal) to food, 2. Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and 3. Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein. 4. With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing; 5. If female of child-bearing potential, must have a negative urine or serum pregnancy test; 6. For women of childbearing potential, must agree to,during the treatment period and for 60 days after the last dose of study drug: * remain abstinent (refrain from heterosexual intercourse), or * use acceptable contraceptive methods (barrier methods, or * oral, injected, or implanted hormonal methods of contraception, or * other forms of hormonal contraception that have comparable efficacy). 7. Plan to remain in the study area of an OUtMATCH clinical research unit (CRU) during the trial; and 8. Be willing to be trained on the proper use of an epinephrine autoinjector for the duration of the study. Exclusion Criteria: Individuals who meet any of the following criteria are not eligible for enrollment as study participants: 1. Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol; 2. Clinically significant laboratory abnormalities at Screening; 3. Dose-limiting symptoms to the placebo portion of the Screening DBPCFC; 4. Sensitivity or suspected/known allergy to any ingredients (including excipients) of the * active or placebo oral food challenge (OFC) material, * multi-allergen oral immunotherapy (OIT), or * drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin). * Note: Guidance for determination of sensitivity to excipients will be detailed in the study's Manual of Procedures (MOP). 5. Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion; 6. Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria: 1. Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines, 2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing, 3. Prior intubation/mechanical ventilation for asthma/wheezing, 4. One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening, 5. Forced expiratory volume in one second (FEV1) \<80 percent of predicted or FEV1/forced vital capacity (FVC) \<75 percent, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), or 6. Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosing chart). 7. History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation; 8. Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening; 9. Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical); 10. Past or current history of eosinophilic gastrointestinal (GI) disease within three years of Screening; 11. Past or current history of cancer, or currently being investigated for possible cancer; 12. Previous adverse reaction to omalizumab; 13. Past or current history of any immunotherapy to any of the foods being treated in this study (e.g., OIT, sublingual immunotherapy \[SLIT\], EPIT) within 6 months of Screening; 14. Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within six months of Screening; 15. Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Note: Individuals tolerating maintenance allergen immunotherapy can be enrolled; 16. Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs,or OFCs; 17. Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening; 18. Use of investigational drugs within 24 weeks of Screening; 19. Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab or placebo for omalizumab; 20. Has a first-degree relative already enrolled in the study; or 21. Past or current medical problems (e.g., severe latex allergy), history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may: * pose additional risks from participation in the study, * may interfere with the participant's ability to comply with study requirements, or * may impact the quality or interpretation of the data obtained from the study.

Locations (10)

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

Little Rock, Arkansas, United States

Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

Stanford, California, United States

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, United States

Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics

Atlanta, Georgia, United States

Johns Hopkins Children's Center: Department of Allergy & Immunology

Baltimore, Maryland, United States

Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

New York, New York, United States

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill, North Carolina, United States

Children's Hospital of Philadelphia: Division of Allergy and Immunology

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center: Division of Allergy and Immunology

Dallas, Texas, United States

Outcomes

Primary Outcomes

Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-Limiting Symptoms During the DBPCFC Conducted at the End of Treatment Stage 1

Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Secondary Outcomes

Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥1000 mg of Cashew Protein Without Dose-limiting Symptoms During the DBPCFC Conducted at the End of Stage 1

Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥1000 mg of Milk Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1

Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥1000 mg of Egg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1

Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC), at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC), at the End of Stage

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥1000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥1000mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume ≥1 Dose of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Number of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1.

Number of participants who successfully consume 2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Milk Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Hazelnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Walnut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for at Least Two Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume 2 Doses of 2000 mg of Food Protein Without Dose-limiting Symptoms for All Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 1

Number of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Foods Consumed at a Single Dose of ≥600 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1.

Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Foods Consumed at a Single Dose of ≥1000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1.

Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1

Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Foods Consumed at 2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1

Number of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Time frame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2

Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.