Multi OIT to Test Immune Markers After Minimum Maintenance Dose

NCT03181009 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: eProtocol 39519
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.

Conditions

Food Allergy

Keywords

Oral Immunotherapy; Omalizumab; OIT; Xolair

Outcome Measures

Primary Outcomes (1)

• Change in Allergen-specific Serum IgG4 and IgE

  Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)

  18 weeks

Study Arms (2)

Group A (300 mg maintenance dose)

EXPERIMENTAL

After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.

Drug: Omalizumab; Drug: Food Flour Allergens

Group B (1200 maintenance dose)

ACTIVE COMPARATOR

After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.

Drug: Omalizumab; Drug: Food Flour Allergens

Interventions

Omalizumab DRUG

All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.

Also known as: Xolair

Group A (300 mg maintenance dose); Group B (1200 maintenance dose)

Food Flour Allergens DRUG

The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.

Also known as: Food flours

Group A (300 mg maintenance dose); Group B (1200 maintenance dose)

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 2 to 25 years with clinical history of allergy to at least two of the following: milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut and/or shrimp and/or cod and/or salmon and
• Sensitivity to food allergens documented by a positive skin prick test result greater than or equal to 6mm wheal diameter to each allergen or
• ImmunoCAP IgE level \>4kU/L for each allergen and
• If female of child bearing potential, a negative urine pregnancy test before being allowed to participate in the study (week 0) and
• A plan to remain in the study area of the research center during the trial and
• Be trained on the proper use of the Epinephrine autoinjector and agree to follow epi training to be allowed to enroll in the study and
• If female of child-bearing potential, willing to be compliant with a medically-approved method of contraception (please see Pregnancy section in this IND document) and
• Agree to eliminate other known food allergens from subject's diet so as not to confound the safety and efficacy data from the study and
• Avoid open or blinded food challenges to food allergens

You may not qualify if:

• Previous anaphylactic reaction to Omalizumab
• A history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma
• Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease)
• An average forced expiratory volume at one second (FEV1) or peak expiratory flow rate (PEF) less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, or a food challenge visit
• Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical)
• Routinely using medication that could induce adverse gastrointestinal reactions during the study
• Refusing to sign or follow the Epinephrine autoinjector Training Form
• Pregnant or breast feeding women
• Unwilling to avoid other allergens outside this study
• Concurrent/prior use of immunomodulatory therapy (within 6 months)
• A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis.

Sponsors & Collaborators

• University of California, Los Angeles: collaborator
• Andrew Long, PharmD: lead

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

Sean N. Parker Center for Allergy and Asthma Research at Stanford

Mountain View, California, 94040, United States

Location

Related Publications (1)

• Sindher SB, Kumar D, Cao S, Purington N, Long A, Sampath V, Zedeck SS, Woch MA, Garcia-Lloret M, Chinthrajah RS. Phase 2, randomized multi oral immunotherapy with omalizumab 'real life' study. Allergy. 2022 Jun;77(6):1873-1884. doi: 10.1111/all.15217. Epub 2022 Jan 24.

  PMID: 35014049 RESULT

Related Links

• Sean N. Parker Center for Allergy and Asthma Research
• Research Registry for the Sean N. Parker Center for Allergy and Asthma Research

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr Andres Alvarez Pinzon, Director of Regulatory Affairs and Translational Medicine
• Organization: The Sean N. Parker Center for Allergy and Asthma Research at Stanford University

andresap@stanford.edu

650 - 521 - 7237

Study Officials

• Kari C Nadeau, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinded labeling (Individual dosing cups will mention a choice of two doses the participant could be assigned to). Oat flour is used as the filler to create equal volumes for all doses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Pulmonary and Critical Care Medicine) and of Pediatrics (Allergy and Clinical Immunology)

Model Details: This is a phase 2 multi site study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, egg, milk, wheat, soy, cashew, walnut, almond, hazelnut, sesame seed, cod, salmon and shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. The subject's allergens will be introduced after receiving the third omalizumab dose. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: June 8, 2017
• Study Start: July 31, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 30, 2019
• Last Updated: April 27, 2026
• Results First Posted: September 20, 2019

Record last verified: 2020-04

Locations

US (2)