Multi Immunotherapy to Test Tolerance and Xolair

NCT02626611 | Completed Phase 2 Results DMC

• 1 other identifier: 28942
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted at multiple centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in Investigational New Drug (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens will be introduced in a rush desensitization day at week 8. Subjects will return to clinic to escalate the dose of their allergens until 2,000mg protein of each allergen is reached Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to one of three double blinded arms: Arm A- continue with current dose (2000 mg each food allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to each allergen at week 36. The final challenge of week 36 will be the final end of study visit. Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects and their parents/guardians will receive extensive education on food allergy reactions and medication use.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported.

  Number of FA participants who pass a DBPCFC to 2,000 mg each of 2 allergens (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.

  36 weeks

Secondary Outcomes (4)

• The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported.

  36 weeks

• The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 3 Allergens (When Applicable) Separately at Week 36, Will be Reported.

  36 weeks

• The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 4 Allergens (When Applicable) Separately at Week 36, Will be Reported.

  36 weeks

• The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 5 Allergens (When Applicable) Separately at Week 36, Will be Reported.

  36 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.

Drug: Omalizumab; Drug: Food Flour Buildup

Low Dose Food

ACTIVE COMPARATOR

Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.

Drug: Omalizumab; Drug: Food Flour Buildup

High Dose Food

ACTIVE COMPARATOR

Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.

Drug: Omalizumab; Drug: Food Flour Buildup

Interventions

Omalizumab DRUG

Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.

Also known as: Xolair

High Dose Food; Low Dose Food; Placebo

Food Flour Buildup DRUG

Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized.

High Dose Food; Low Dose Food; 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
• Positive skin prick test result greater than or equal to 6 mm wheal diameter to each allergen OR
• ImmunoCAP Immunoglobulin E (IgE) level \>4 kilo Unit/Liter 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 Clinical Laboratory Improvement Amendment (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 \>2,000 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 betablockers (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 Oral Immunotherapy 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, nontraditional forms of allergen immunotherapy (e.g., oral or sublingual)
• Severe asthma (2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5 or 6) at time of enrollment

Sponsors & Collaborators

• Kari Christine Nadeau: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Children's Hospital of Philadelphia: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Children's Hospital Los Angeles: collaborator
• University of Washington: collaborator

Study Sites (7)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Sean N. Parker Center for Allergy Research at Stanford University

Mountain View, California, 94040, United States

Location

Lurie Children's Hospital, Northwestern University

Chicago, Illinois, 60611, United States

Location

Mt. Sinai, Icahn School of Medicine

New York, New York, 10029, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Northwest Asthma & Allergy Center

Seattle, Washington, 98115, United States

Location

Related Publications (1)

• Andorf S, Purington N, Kumar D, Long A, O'Laughlin KL, Sicherer S, Sampson H, Cianferoni A, Whitehorn TB, Petroni D, Makhija M, Robison RG, Lierl M, Logsdon S, Desai M, Galli SJ, Rael E, Assa'ad A, Chinthrajah S, Pongracic J, Spergel JM, Tam J, Tilles S, Wang J, Nadeau K. A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued vs Discontinued Dosing in Multifood Allergic Individuals. EClinicalMedicine. 2019 Jan 21;7:27-38. doi: 10.1016/j.eclinm.2018.12.006. eCollection 2019 Jan.

  PMID: 31193674 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

Results Point of Contact

• Title: Dr. Kari Nadeau
• Organization: Stanford

knadeau@stanford.edu

650-867-4592

Study Officials

• Nadeau 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 10, 2015
• Study Start: December 1, 2015
• Primary Completion: November 16, 2016
• Study Completion: November 16, 2016
• Last Updated: December 18, 2017
• Results First Posted: December 18, 2017

Record last verified: 2017-12

Locations

US (7)