Clinical trial NCT03881696: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Official title: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (CoFAR-11)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Peanut Allergy
Multi-food Allergy
Keywords: peanut allergic
multi-food allergic
omalizumab
placebo
multi-allergen oral immunotherapy (OIT)
double-blind placebo-controlled food challenge (DBPCFC)
oral food challenge (OFC)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Genentech, Inc.
name: Novartis Pharmaceuticals
name: Rho Federal Systems Division, Inc.
First posted: 2019-03-19
Enrollment: 471
Sex: ALL
Minimum age (years): 1
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
Secondary outcomes:
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: Number of Participants Who Successfully Consume a Single Dose of ≥600 mg of Food Protein Without Dose-limiting Symptoms for at Least Three Treated Food Allergens During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC), at the End of Stage
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: Proportion 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: Proportion 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: Proportion 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation]
measure: Proportion 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: Number of Foods Consumed at 2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1.
timeFrame: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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) at the End of Stage 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage treatment initiation
measure: 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) at the End of Stage 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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) at the End of Stage 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume ≥1 Dose of 2000mg of Egg Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume ≥1 Dose of 2000mg of Wheat Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume ≥1 Dose of 2000mg of Cashew Protein Without Dose-limiting Symptoms During the Double-blind Placebo-controlled Oral Food Challenge (DBPCFC) at the End of Stage 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: Time Frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: 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
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Proportion of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Participants Who Successfully Consume 3 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 2
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Foods Consumed at a Single Dose of ≥600 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Foods Consumed at a Single Dose of ≥1000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Foods Consumed at ≥2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: Number of Foods Consumed at 3 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2.
timeFrame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation
measure: During Stage 1: Occurrence of Adverse Event(s) Related to Study Therapy Regimen, Omalizumab Versus Placebo
timeFrame: Up to 20 Weeks after initiating Stage 1 randomized treatment initiation
measure: During Stage 1 OLE : Occurrence of Adverse Event(s) Related Study to Therapy Regimen, Open Label Extension (OLE)
timeFrame: Up to 28 Weeks after initiating Stage 1 Open Label omalizumab study therapy regimen
measure: During Stage 2: Occurrence of Adverse Event(s) Related to Study Therapy Regimen
timeFrame: Up to 64 Weeks after initiating Stage 2 study therapy regimen
measure: During Stage 3: Occurrence of Adverse Event(s) Related to Oral Food Intake
timeFrame: Up to 2 years after initiating Stage 3 Oral Food Intake regimen
measure: Number of Weeks in Each Eight-week Period During Stage 3 Where ≥300 mg Protein of Each Food is Consumed at Least Twice Per Week
timeFrame: From initial 8-week period during Stage 3 up to the last possible 8-week period during Stage 3 (i.e., Up to N=13 possible 8-week intervals during a 2-year period of time in Stage 3)
measure: Number of Weeks in Each Eight-week Period During Stage 3 Where Each Food is Not Consumed
timeFrame: From initial 8-week period during Stage 3 up to the last possible 8-week period during Stage 3 (i.e., Up to N=13 possible 8-week intervals during a 2-year period of time in Stage 3)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
state: Arkansas
city: Stanford
country: United States
facility: Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research
state: California
city: Denver
country: United States
facility: National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
state: Colorado
city: Atlanta
country: United States
facility: Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center: Department of Allergy & Immunology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
state: New York
city: Chapel Hill
country: United States
facility: North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia: Division of Allergy and Immunology
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center: Division of Allergy and Immunology
state: Texas
Study officials:
affiliation: Department of Pediatrics at the Johns Hopkins University School of Medicine
name: Robert A. Wood, MD
role: STUDY_CHAIR
affiliation: Department of Medicine, Stanford University School of Medicine
name: Sharon Chinthrajah, MD
role: STUDY_CHAIR
References:
citation: Sampson HA, Berin MC, Plaut M, Sicherer SH, Jones S, Burks AW, Lindblad R, Leung DYM, Wood RA. The Consortium for Food Allergy Research (CoFAR): The first generation. J Allergy Clin Immunol. 2019 Feb;143(2):486-493. doi: 10.1016/j.jaci.2018.12.989. Epub 2018 Dec 23.
citation: Wood RA, Togias A, Sicherer SH, Shreffler WG, Kim EH, Jones SM, Leung DYM, Vickery BP, Bird JA, Spergel JM, Iqbal A, Olsson J, Ligueros-Saylan M, Uddin A, Calatroni A, Huckabee CM, Rogers NH, Yovetich N, Dantzer J, Mudd K, Wang J, Groetch M, Pyle D, Keet CA, Kulis M, Sindher SB, Long A, Scurlock AM, Lanser BJ, Lee T, Parrish C, Brown-Whitehorn T, Spergel AKR, Veri M, Hamrah SD, Brittain E, Poyser J, Wheatley LM, Chinthrajah RS. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024 Mar 7;390(10):889-899. doi: 10.1056/NEJMoa2312382. Epub 2024 Feb 25.