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Phase 2 N=48 Randomized Double-blind Treatment

Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

Food Allergy

Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36 — 30; 4 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Xolair (Drug); Placebo (Drug)
Age
Pediatric, Adult · 4+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Aug 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36
30; 4
SECONDARY
Desensitization Measured to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36
21; 2

Summary

This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36* participants will receive Xolair for 16 weeks while 12* will receive corresponding placebo instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These 12 controls are not part of the randomization. The total number of participants randomized to the two arms is 48*.

Eligibility Criteria

Inclusion Criteria

  • Participant and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.
  • Age 4 to 55 years with moderate to severe allergy to 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
  • ositive skin prick test result greater than or equal to 6 mm wheal diameter to each allergen OR
  • ImmunoCAP IgE level >4kU/L for each allergen and
  • A clinical reaction during a DBPCFC to small doses of food defined as 1,500 kU/L
  • Previous adverse reaction to Xolair
  • A history of severe anaphylaxis (defined as requiring intubation or admission to an ICU) to food allergens that will be used in this study
  • Unstable angina, significant arrhythmia, uncontrolled hypertension, current smokers, 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 participant.
  • Current use of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical)
  • Routine use of medication that could induce adverse gastrointestinal reactions during the study
  • Refusing to sign the Epinephrine autoinjector Training Form
  • Pregnant or breast feeding women
  • A history of oat allergy (since oat is the placebo agent in the DBPCFC), or an objective reaction to the screening DBPCFC to oat
  • Unwilling to avoid all food allergen-containing items except those given as part of the OIT as well as any other food allergens you are allergic to that are not included in the 10 foods listed in the study
  • Concurrent/prior use of immunomodulatory therapy (within 1 month) ie, omalizumab, non-traditional forms of allergen immunotherapy (e.g., oral or sublingual)
  • Severe asthma (2007 NHLBI Criteria Steps 5 or 6) at time of enrollment
  • Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4) at time of enrollment with any of the following criteria met:
  • FEV1 220 mcg daily fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
  • 1 hospitalization in the past year for asthma or
  • ER visit for asthma within the past six months
  • Use of steroid medications (IV, IM or oral) in the following manners
  • history of daily oral steroid dosing for >1 month during the past year or
  • steroid burst course ( 5 or more days) of 1 mg/kg prednisone) course in the past 3 months or
  • >2 steroid burst courses in the past year
  • Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and/or non-atopic disease within 90 days preceding rush desensitization at week 8or at any time .
  • Inability to discontinue antihistamines for the initial day of escalation, skin testing or OFCs
  • Use of investigational drugs within 24 weeks of participation
  • Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02643862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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