Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181009
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : September 20, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Kari Christine Nadeau, MD PhD, Stanford University

Tracking Information
First Submitted Date  ICMJE April 7, 2017
First Posted Date  ICMJE June 8, 2017
Results First Submitted Date  ICMJE April 1, 2019
Results First Posted Date  ICMJE September 20, 2019
Last Update Posted Date April 20, 2020
Actual Study Start Date  ICMJE July 31, 2017
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
Change in Allergen-specific Serum IgG4 and IgE [ Time Frame: 18 weeks ]
Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
Change in Allergen-specific Serum IgG4 and IgE [ Time Frame: 18 weeks ]
Change in allergen-specific serum IgG4 and IgE
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi OIT to Test Immune Markers After Minimum Maintenance Dose
Official Title  ICMJE A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Food Allergy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Omalizumab
    • Drug: Food Flour Allergens
  • 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.
    Interventions:
    • Drug: Omalizumab
    • Drug: Food Flour Allergens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2019
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181009
Other Study ID Numbers  ICMJE eProtocol 39519
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: pending
Responsible Party Kari Christine Nadeau, MD PhD, Stanford University
Study Sponsor  ICMJE Kari Christine Nadeau, MD PhD
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Kari C Nadeau, MD PhD Stanford University
PRS Account Stanford University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP