Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Phase 3 Completed 471 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Genentech, Inc. · collab Novartis Pharmaceuticals · collab Rho Federal Systems Division, Inc. · collab

RandomizedSequentialTriple-blindTreatment

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Timeline

Start: 2019-07-22
Primary completion: 2023-03-13
Completion: 2025-07-01

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cashew	Unknown	—	Oral
Subject	Egg	Unknown	—	Oral
Subject	Hazelnut	Unknown	—	Oral
Subject	Milk	Unknown	—	Oral
Subject	Omalizumab	Monoclonal antibody	—	Subcutaneous
Subject	Peanut Flour	Protein / enzyme biologic	—	Oral
Subject	Walnut	Unknown	—	Oral
Subject	Wheat	Unknown	—	Oral

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Summary

Timeline

Publications

Drugs

Indications