Phase 3
N=180
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Peanut Allergy · Multi-food Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03881696 ↗Enrolled (actual)
180
Serious AEs
2.8%
Results posted
Jun 2024
Primary outcome: Primary: 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 — 79; 4; 39; 55 Participants — p=<0.00001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Drug); Placebo for Omalizumab (Drug); Multi-Allergen Oral Immunotherapy (Drug); Placebo for Multi-Allergen Oral Immunotherapy (Drug); Double-Blind Placebo-Controlled Food Challenge Based Treatment (Other)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
79; 4; 39; 55 | <0.00001 sig |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1 |
— | — |
| SECONDARY Number of Foods Consumed at 2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 1. |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY 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. |
— | — |
| SECONDARY Number of Foods Consumed at ≥1 Dose of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2. |
— | — |
| SECONDARY Number of Foods Consumed at ≥2 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2. |
— | — |
| SECONDARY Number of Foods Consumed at 3 Doses of 2000 mg Protein Without Dose-limiting Symptoms During the DBPCFC at the End of Stage 2. |
— | — |
| SECONDARY During Stage 1: Occurrence of Adverse Event(s) Related to Study Therapy Regimen, Omalizumab Versus Placebo |
— | — |
| SECONDARY During Stage 1 OLE : Occurrence of Adverse Event(s) Related Study to Therapy Regimen, Open Label Extension (OLE) |
— | — |
| SECONDARY During Stage 2: Occurrence of Adverse Event(s) Related to Study Therapy Regimen |
— | — |
| SECONDARY During Stage 3: Occurrence of Adverse Event(s) Related to Oral Food Intake |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Number of Weeks in Each Eight-week Period During Stage 3 Where Each Food is Not Consumed |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable;
- 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:
- Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut,
- Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and
- Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein.
- 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:
- Positive SPT (≥4 mm wheal) to food,
- Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and
- Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein.
- With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing;
- If female of child-bearing potential, must have a negative urine or serum pregnancy test;
- 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).
- Plan to remain in the study area of an OUtMATCH clinical research unit (CRU) during the trial; and
- 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:
- 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;
- Clinically significant laboratory abnormalities at Screening;
- Dose-limiting symptoms to the placebo portion of the Screening DBPCFC;
- 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).
- Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion;
- Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria:
- Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines,
- 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,
- Prior intubation/mechanical ventilation for asthma/wheezing,
- One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening,
- Forced expiratory volume in one second (FEV1) 500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosi
Data sourced from ClinicalTrials.gov (NCT03881696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.