Protocol design and synopsis: Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults with Food Allergy (OUtMATCH)
Year: 2022
Type: article
Study design: Study Protocol
Abstract: Background: Food allergy is common and causes substantial morbidity and even mortality. Safe and effective treatments for food allergy would therefore be highly desirable, especially for individuals with multiple food allergies. Objectives: Our aim was to describe a phase 3 study on treatment of patients with multiple food allergies with omalizumab. Methods: The study was developed as a collaboration between the Consortium for Food Allergy Research, the National Institute of Allergy and Infectious Diseases, and 2 industry sponsors (Genentech and Novartis). Results: The study is currently under way, enrolling participants from age 1 year to age 55 years who are allergic to peanut and at least 2 other foods (including milk, egg, wheat, cashew, hazelnut, and walnut). The study is designed to address 3 major questions. First, stage 1 will study the potential value of omalizumab for the treatment of patients with peanut allergy and at least 2 other common food allergens. Second, stage 2 will directly compare treatment of patients with multifood allergies using omalizumab as monotherapy versus treatment with omalizumab-facilitated multiallergen oral immunotherapy in which omalizumab is used as an adjunctive treatment. Third, stage 3 will address the longer-term outcomes following these treatment approaches, including the introduction of dietary forms of the study foods to induce or maintain desensitization. Conclusions: This phase 3 study will provide important information on the potential of omalizumab to treat patients with multiple food allergies.
Authors: Robert A. Wood, R. Sharon Chinthrajah, Amanda K. Rudman Spergel, Denise C. Babineau, Scott H. Sicherer, Edwin H. Kim, Wayne G. Shreffler, Stacie M. Jones, Donald Y.M. Leung, Brian P. Vickery, J. Andrew Bird, Jonathan M. Spergel, Michael Kulis, Ahmar Iqbal, Derrick Kaufman, Dale T. Umetsu, Monica Ligueros-Saylan, Alkaz Uddin, Robert B. Fogel, Stephanie Lussier, Kim Mudd, Julian Poyser, Martin MacPhee, Maria Veri, Wendy Davidson, Sanaz Hamrah, Andrew Long, Alkis Togias
Institutions: Johns Hopkins University, Johns Hopkins Medicine, Stanford University, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Rho (United States), Icahn School of Medicine at Mount Sinai, University of North Carolina at Chapel Hill, Massachusetts General Hospital, Arkansas Children's Hospital, University of Arkansas for Medical Sciences, National Jewish Health, Emory University, Children's Healthcare of Atlanta, The University of Texas Southwestern Medical Center, Children's Hospital of Philadelphia, University of Pennsylvania, Roche (United States), Genentech, Novartis (Switzerland)
Language: English
Subfield: Immunology and Allergy
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,000
Funders: U.S. Department of Defense, AstraZeneca, Novartis, Sanofi, Massachusetts General Hospital, Emory University, Johns Hopkins University, University of Arkansas for Medical Sciences, Regeneron Pharmaceuticals, Immune Tolerance Network, Aimmune Therapeutics, Incyte, Astellas Pharma, LEO Pharma, National Institutes of Health, Genentech, School of Medicine, Emory University, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences, School of Medicine, University of North Carolina at Chapel Hill
Awards: Clinical Research Unit: Johns Hopkins University, G2015897480, G341259862, Harvard Clinical and Translational Science Center (UL1), NEW HORIZONS IN THE PREVENTION AND TREATMENT OF FOOD ALLERGY, G383562631, G3846021062, Arkansas Center for Food Allergy Research (ArCOFAR), G4452204916, Mount Sinai's COFAR Clinical Research Unit and Clinical Trial (The "ADVANCE" Trial)., G5404520674, G5778679195, Expanding Translational Research in Arkansas, G6181769117, Immune progression and plasticity in relation to child age, G6583636337, North Carolina Translational and Clinical Science Institute (NC TraCS), G6926631758, G7396055209, Harvard Clinical and Translational Science Center (UL1), Johns Hopkins Institute for Clinical and Translational Research, G8074519811, Colorado Clinical and Transational Sciences Institute, G8247908056, Harvard Clinical and Translational Science Center, G8622159918, University of North Carolina Food Allergy Initiative, National Jewish Health CoFAR Clinical Research Unit, Mount Sinai's CoFAR Clinical Research Center, Arkansas Center for Food Allergy Research (ArCOFAR)
OpenAlex ID: W4286515246