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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

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

OUtMATCH 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.Check my eligibility

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.See study design

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.

OUtMATCH Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

OUtMATCH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

33. 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.

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

+92 more

OUtMATCH 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rho Federal Systems Division, Inc.Industry Sponsor

41 Previous Clinical Trials

13,138 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,196,916 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,480,998 Total Patients Enrolled

Media Library

Multi-Allergen Oral Immunotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03881696 — Phase 3

Peanut Allergy Research Study Groups: Stage 1: Placebo for Omalizumab as Monotherapy, Stage 1: Omalizumab OLE, Stage 2: Omalizumab, Stage 3: DBPCFC Based Treatment, Stage 1:Omalizumab as Monotherapy, Stage 2: Omalizumab + Placebo OIT, Stage 2: Omalizumab-Facilitated OIT

Peanut Allergy Clinical Trial 2023: Multi-Allergen Oral Immunotherapy Highlights & Side Effects. Trial Name: NCT03881696 — Phase 3

Multi-Allergen Oral Immunotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03881696 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical facilities is this experiment being conducted presently?

"The 11 clinical trial sites for this study are as follows: -Children's Hospital of Philadelphia: Division of Allergy and Immunology in Philadelphia, Pennsylvania-Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit in Boston, Massachusetts-Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology in New york, New York -10 other locations."

Answered by AI

What are Multi-Allergen Oral Immunotherapy's most popular applications?

"Multi-Allergen Oral Immunotherapy is a medical intervention used to help those with allergies to airborne substances. Additionally, it can also assist patients who suffer from moderate asthma that is not controlled by other methods, such as inhaled corticosteroids or histamine h1 antagonists."

Answered by AI

Does this research project allow people who are over 18 years old to participate?

"According to the study's prerequisites, patients that 1 to 55 years old can apply to participate. Out of the 296 similar clinical trials, this is one of the 94 trials catering to a younger demographic and 202 trials for older patients."

Answered by AI

How can I sign up for participation in this research project?

"This study, which is testing a new peanut allergy treatment, is seeking 225 participants who are between 1 year and 55 years old. To be eligible, patients must also be willing to either abstain from heterosexual intercourse or use effective contraception methods."

Answered by AI

Are there other medical studies that have used Multi-Allergen Oral Immunotherapy?

"The first study into Multi-Allergen Oral Immunotherapy took place a decade ago at the London Chest Hospital. Since that time, there have been 103 completed studies with 23 more ongoing. The majority of the active studies are located in Philadelphia, Pennsylvania."

Answered by AI

Could you detail the risks associated with Multi-Allergen Oral Immunotherapy?

"There is some evidence from earlier clinical trials to support the efficacy of this immunotherapy, as well as data from multiple rounds of safety testing, so it received a score of 3."

Answered by AI