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

NCT02643862 | Completed Phase 1 Results DMC

• 2 other identifiers: 123U19AI104209
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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\*.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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

  Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36. Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)

  36 weeks

Secondary Outcomes (1)

• 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

  36 weeks

Study Arms (2)

xolair

ACTIVE COMPARATOR

Pts will be randomized to receive xolair at a 3 active:1 placebo ratio

Drug: Xolair

Placebo

PLACEBO COMPARATOR

This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair

Drug: Placebo

Interventions

Xolair DRUG

Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria

Also known as: omalizumab

xolair

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 \< dose of 500 mg food protein
• No clinical reaction observed during the placebo (oat) challenge and
• If female, must have a negative urine pregnancy test on the same day (using a CLIA approved urine test)
• If female, of child-bearing potential, must agree to be compliant with a medically-approved method of contraception (please see Pregnancy section under Patient Disposition in this protocol)
• Plan to remain in the study area of the research center during the trial
• Be trained on the proper use of the Epinephrine autoinjector
• Avoid open or blinded food challenges to other allergens outside this study

You may not qualify if:

• Inability or unwillingness of a participant/parent/guardian to give written informed consent or comply with study protocol
• History of cardiovascular disease
• History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the participant's health or safety in this study or the participant's ability to comply with the study protocol
• A total IgE at screening of \>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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Sean N Parker Allergy Reseach Center at Stanford University

Mountain View, California, 94040, United States

Location

Related Publications (2)

• Manohar M, Dunham D, Gupta S, Yan Z, Zhang W, Minnicozzi S, Kirkey M, Bunning B, Roy Chowdhury R, Galli SJ, Boyd SD, Kost LE, Chinthrajah RS, Desai M, Oettgen HC, Maecker HT, Yu W, DeKruyff RH, Andorf S, Nadeau KC. Immune changes beyond Th2 pathways during rapid multifood immunotherapy enabled with omalizumab. Allergy. 2021 Sep;76(9):2809-2826. doi: 10.1111/all.14833. Epub 2021 May 29.

  PMID: 33782956 DERIVED

• Andorf S, Purington N, Block WM, Long AJ, Tupa D, Brittain E, Rudman Spergel A, Desai M, Galli SJ, Nadeau KC, Chinthrajah RS. Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2018 Feb;3(2):85-94. doi: 10.1016/S2468-1253(17)30392-8. Epub 2017 Dec 12.

  PMID: 29242014 DERIVED

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

Limitations and Caveats

The mechanistic 12 controls are not part of the randomization. The arms that are randomized are 48\*. Mechanistic controls did not undergo therapy.

Results Point of Contact

• Title: Dr. Kari Nadeau
• Organization: Stanford

knadeau@stanford.edu

650-867-4592

Study Officials

• Kari Nadeau, MD PhD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Director

Model Details: 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\*.

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 31, 2015
• Study Start: March 18, 2015
• Primary Completion: August 20, 2016
• Study Completion: August 20, 2016
• Last Updated: January 12, 2018
• Results First Posted: October 25, 2017

Record last verified: 2017-12

Locations

US (1)