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Clinical trialNCT03881696CompletedPhase 3Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment471Multi-food AllergyPeanut Allergy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Robert A. Wood, MD

    Department of Pediatrics at the Johns Hopkins University School of Medicine

    Study Chair
  • Sharon Chinthrajah, MD

    Department of Medicine, Stanford University School of Medicine

    Study Chair

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Arkansas Children'S Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

    Little Rock, Arkansas, United States

  • Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

    Stanford, California, United States

  • National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

    Denver, Colorado, United States

  • Emory University School of Medicine: Children'S Healthcare of Atlanta Pediatrics

    Atlanta, Georgia, United States

  • Johns Hopkins Children'S Center: Department of Allergy & Immunology

    Baltimore, Maryland, United States

  • Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit

    Boston, Massachusetts, United States

  • Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

    New York, New York, United States

  • North Carolina Children'S Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

    Chapel Hill, North Carolina, United States

  • Children'S Hospital of Philadelphia: Division of Allergy and Immunology

    Philadelphia, Pennsylvania, United States

  • University of Texas Southwestern Medical Center: Division of Allergy and Immunology

    Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Multi-Allergen Oral ImmunotherapyOmalizumab →Placebo for Multi-Allergen Oral ImmunotherapyPlacebo for Omalizumab
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 Jul 2019
Primary completion
13 Mar 2023
Completion
1 Jul 2025
Last update posted
10 Sept 2025
Registered enrollment
471
Registry id
NCT03881696

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.