Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi OIT to Test Immune Markers After Minimum Maintenance Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03181009
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University

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.

Condition or disease Intervention/treatment Phase
Food Allergy Drug: Omalizumab Drug: Food Flour Allergens Phase 2

Detailed Description:

This is a phase 2 multisite study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, milk, egg, soy, wheat, cashew, walnut, almond, hazelnut, cod, salmon, sesame, 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.

Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations.

Omalizumab is approved by the European Medicines Agency (European FDA) and by the US FDA. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: 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
Primary Purpose: Treatment
Official Title: A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Group A (300 mg maintenance dose)
After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.
Drug: Omalizumab
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.
Other Name: Xolair

Drug: Food Flour Allergens
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.
Other Name: Food flours

Active Comparator: Group B (1200 maintenance dose)
After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.
Drug: Omalizumab
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.
Other Name: Xolair

Drug: Food Flour Allergens
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.
Other Name: Food flours




Primary Outcome Measures :
  1. Change in allergen-specific serum IgG4 and IgE [ Time Frame: 18 weeks ]
    Change in allergen-specific serum IgG4 and IgE



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181009


Contacts
Layout table for location contacts
Contact: Kari C Nadeau, MD PhD 650-724-0293 snpcenterallergy_inquiry <snpcenterallergy_inquiry@stanford.edu>

Locations
Layout table for location information
United States, California
Sean N. Parker Center for Allergy and Asthma Research Recruiting
Mountain View, California, United States, 94040
Contact: Kari c Nadeau, MD, PhD       knadeau@stanford.edu   
Contact: Tina Sindher, MD       tina.sindher@stanford.edu   
Sponsors and Collaborators
Kari Christine Nadeau
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Kari C Nadeau, MD PhD Stanford University

Additional Information:
Layout table for additonal information
Responsible Party: Kari Christine Nadeau, Professor of Medicine (Pulmonary and Critical Care Medicine) and of Pediatrics (Allergy and Clinical Immunology), Stanford University
ClinicalTrials.gov Identifier: NCT03181009     History of Changes
Other Study ID Numbers: eProtocol 39519
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: pending

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kari Christine Nadeau, Stanford University:
Oral Immunotherapy
Omalizumab
OIT
Xolair

Additional relevant MeSH terms:
Layout table for MeSH terms
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents