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Omalizumab for Peanut Allergy (OUtMATCH Trial)

Phase 3

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein

Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein

Must not have

Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria:

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether omalizumab, an allergy medication, can help people with peanut allergies eat foods they're allergic to without having severe symptoms.

Who is the study for?

This trial is for people aged 1-55 with peanut and at least two other specific food allergies (milk, egg, wheat, cashew, hazelnut, walnut). They must have a positive skin test and immunoglobulin E levels for these allergens. Participants should be near the research unit during the study and trained to use an epinephrine autoinjector. Women of childbearing age must not be pregnant or breastfeeding and agree to use contraception.

What is being tested?

The study tests if omalizumab can help participants consume foods without symptoms compared to a placebo. It's randomized and double-blind: neither doctors nor patients know who gets real treatment or placebo. The focus is on tolerating peanuts and two other allergens after treatment.

What are the potential side effects?

Omalizumab may cause injection site reactions like pain or swelling, cold-like symptoms such as runny nose or sneezing, headaches, fatigue, joint pain, dizziness. Rarely it might lead to more serious issues like heart problems or severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a reaction to ≤100 mg of peanut protein during a blind test.

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I react to ≤300 mg of certain foods with severe symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe or poorly controlled asthma.

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I have not taken steroids for more than two days in the last month, except for asthma.

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I have or am being checked for cancer.

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I haven't had certain immune therapies like Xolair or Dupixent in the last 6 months.

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My lung function test shows less than 80% of the expected value or my FEV1/FVC ratio is below 75%.

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I've had 2 or more steroid treatments for asthma in the last 6 months.

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I am currently taking steroids, antidepressants, or beta-blockers.

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I use more than 500 mcg daily of inhaled corticosteroids for asthma or COPD.

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I have been on a breathing machine for asthma before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

During Stage 1 OLE : Occurrence of Adverse Event(s) Related Study to Therapy Regimen, Open Label Extension (OLE)

During Stage 1: Occurrence of Adverse Event(s) Related to Study Therapy Regimen, Omalizumab Versus Placebo

During Stage 2: Occurrence of Adverse Event(s) Related to Study Therapy Regimen

+83 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Stage 3: DBPCFC Based TreatmentExperimental Treatment1 Intervention

DBPCFC Based Treatment-Long-term Follow-up Treatment Plan for Peanut and Each of the Two Other Participant-Specific Foods. Upon completion of the DBPCFCs at the end of Stage 1 OLE or Stage 2, each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods based on the results of the DBPCFCs. A treatment plan will include instructions for one of the following: * Long-term follow-up with dietary consumption of a food; * Long-term follow-up with avoidance of a food; or * Rescue OIT for a food. The treatment plan for each food may change throughout Stage 3 depending on a participant's response to treatment. Once a participant enters Stage 3, the participant will have a minimum of 12 months follow-up until at least December 2022. Note: Participants will be instructed to strictly avoid a food if they receive rescue OIT for the food during Stage 3.

Group II: Stage 2: Omalizumab-Facilitated OITExperimental Treatment2 Interventions

OIT: oral immunotherapy-Omalizumab as Adjunct Therapy to Multi-Allergen Oral Immunotherapy Participants randomized to open label omalizumab + Multi-allergen OIT for eight weeks, followed by placebo for omalizumab + Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.

Group III: Stage 2: Omalizumab + Placebo OITExperimental Treatment2 Interventions

OIT: oral immunotherapy Participants randomized to open label omalizumab + placebo for Multi-allergen OIT for eight weeks, followed by omalizumab + placebo for Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.

Group IV: Stage 2: OmalizumabExperimental Treatment1 Intervention

Participants will receive eight weeks of treatment with open label omalizumab in accordance with the omalizumab dosing table specified in the study protocol, administered by subcutaneous injection. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After completion of eight weeks of open label omalizumab, participants will be randomized 1:1 to either: * Omalizumab-facilitated oral immunotherapy (OIT): Open label omalizumab + Multi-allergen OIT for eight weeks, followed by placebo for omalizumab + Multi-allergen OIT for 44 weeks OR * Omalizumab + placebo OIT: Open label omalizumab + placebo for Multi-allergen OIT for eight weeks, followed by omalizumab + placebo for Multi-allergen OIT for 44 weeks. Throughout Stage 2, each participant will be instructed to strictly avoid all foods to which they are allergic.

Group V: Stage 1:Omalizumab as MonotherapyExperimental Treatment1 Intervention

Eligible participants are randomized to receive omalizumab by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 16 weeks of treatment, each participant will complete double-blind placebo-controlled food challenge (DBPCFCs) to each of their three specific foods to a cumulative dose of 6044 mg protein of each food. Throughout Stage 1, each participant will be instructed to strictly avoid all foods to which they are allergic. The first 60 participants who complete all four DBPCFCs at the end of Stage 1 will participate in the Stage 1 Open Label Extension (OLE).All other participants who complete all four DBPCFCs will move Stage 2 of the study.

Group VI: Stage 1: Omalizumab OLEExperimental Treatment1 Intervention

OLE: Open Label Extension, Long-Term Treatment with Omalizumab. Participants will receive 24 weeks of open label omalizumab in accordance with the omalizumab dosing table defined in the study protocol. Omalizumab is administered by subcutaneous injection either every 2 weeks or every 4 weeks for 24 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 24 weeks of treatment, each participant will complete DBPCFCs to each of their three specific foods to a cumulative dose of 8044 mg protein of each food. Each participant who completes all four DBPCFCs at the end of the Stage 1 OLE will move on to Stage 3 of the study. Throughout Stage 1 OLE, each participant will be instructed to strictly avoid all foods to which they are allergic.

Group VII: Stage 1: Placebo for Omalizumab as MonotherapyPlacebo Group1 Intervention

Eligible participants are randomized to receive placebo for omalizumab by subcutaneous injection either every 2 weeks or every 4 weeks for 16 to 20 weeks. The dose administered and the dosing interval are determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. After 16 weeks of treatment, each participant will complete DBPCFCs to each of their three specific foods to a cumulative dose of 6044 mg protein of each food. Throughout Stage 1, each participant will be instructed to strictly avoid all foods to which they are allergic. The first 60 participants who complete all four DBPCFCs at the end of Stage 1 will participate in the Stage 1 OLE. All other participants who complete all four DBPCFCs will move Stage 2 of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omalizumab

2006

Completed Phase 4

~2350

0 / 11Eligibility criteria met