RECRUITING

Omalizumab Weight-Based Dosing Efficacy Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

Official Title

Omalizumab Weight-Based Dosing Efficacy Trial

Quick Facts

Study Start:2025-06-01

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06943534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk) * Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods * A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food * Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)	* Weight \>80 kg at time of screening * Clinically significant laboratory abnormalities at screening. * Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab. * Poorly controlled or severe asthma/wheezing at screening * History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation. * Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening. * Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers. * Past or current history of eosinophilic gastrointestinal disease within three years of screening. * Past or current history of cancer, or currently being investigated for possible cancer. * Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening. * Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening. * Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs. * Pregnant or breastfeeding or intending to become pregnant during the study. * Evidence of clinically significant chronic disease.

Inclusion Criteria

Exclusion Criteria

* A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk)
* Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods
* A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food
* Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)

* Weight \>80 kg at time of screening
* Clinically significant laboratory abnormalities at screening.
* Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab.
* Poorly controlled or severe asthma/wheezing at screening
* History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation.
* Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening.
* Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.
* Past or current history of eosinophilic gastrointestinal disease within three years of screening.
* Past or current history of cancer, or currently being investigated for possible cancer.
* Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening.
* Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening.
* Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs.
* Pregnant or breastfeeding or intending to become pregnant during the study.
* Evidence of clinically significant chronic disease.

Contacts and Locations

Study Contact

Jannat Gill

CONTACT

617-643-8683

Jgill@mgh.harvard.edu

Principal Investigator

Wayne Shreffler, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

University of Texas Southwestern

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Wayne Shreffler, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

omalizumab

Additional Relevant MeSH Terms

Allergies
Food Allergy