NCT02626611

Multi Immunotherapy to Test Tolerance and Xolair

A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Tolerance M-TAX Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kari Christine Nadeau · Academic / Other
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will enroll multi food allergic subjects (4-55 years of age) with proven multi food allergies. The investigators anticipate enrolling 70 subjects with multi food allergies at more than one site. Subjects must have food specific Immunoglobulin E \>4 kilo Units/Liter for each allergen or a skin test reactivity to each food allergen greater than or equal to 6mm wheal diameter. In addition, subjects must have a total Immunoglobulin E \<2,000 kilo Units/Liter, a clinical reaction during a double blind placebo controlled food challenge (DBPCFC) with food protein/powder to establish sensitivity to given food protein/powder (pecan, milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut, hazelnut, shrimp, cod, salmon) and no clinical reaction during placebo (oat) as per Chemistry Manufacturing and Control section of Investigational New Drug. Each subject is planned to be enrolled in the active phase of the study for 36 weeks. 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) for patients with severe asthma \>6 years of age, and by the US FDA for patients \>12 years of age. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DRUG	Omalizumab	Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.
DRUG	Food Flour Buildup	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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-11-16
• Completion: 2016-11-16
• First posted: 2015-12-10
• Last updated: 2017-12-18
• Results posted: 2017-12-18

Locations

7 sites across 1 country: United States