Multi Immunotherapy to Test Tolerance and Xolair

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.

Timeline

Start

2015-12

Primary completion

2016-11-16

Completion

2016-11-16

Publications

• 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.

Drugs

Indications