Omalizumab Weight-Based Dosing Efficacy Trial (OWED-T)

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

Study Overview

• Status: Recruiting
• Conditions: Food Allergy; Allergies
• Intervention / Treatment: Drug: 5mg/kg omalizumab injection; Drug: 15mg/kg omalizumab injection

Detailed Description

This research is being conducted to assess the safety and effectiveness of omalizumab for food allergies dosed differently from what is currently FDA approved. The study hypothesizes the current way of dosing omalizumab may not work well for all patients with food allergy and it unnecessarily excludes some individuals with very high allergic antibody (IgE) who may benefit. This study will include subjects regardless of IgE level. One of the goals is to learn more about how safe and effective Omalizumab is for people with these high IgE levels, since this has not been fully studied before.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jannat Gill; Phone Number: 617-643-8683; Email: Jgill@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Wayne Shreffler, MD
      • Contact: Jannat Gill; Phone Number: 614-643-8683; Email: Jgill0@mgh.harvard.edu
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Lauren Herlihy; Email: lherlihy@unc.edu
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern
      • Contact: Dolores Santoyo; Email: Dolores.Santoyo@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

(If meeting above criteria):

• Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients Receiving 5mg/kg of omalizumab; Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.	Drug: 5mg/kg omalizumab injection; 5mg/kg of omalizumab; Other Names: Xolair
Active Comparator: Patients Receiving 15mg/kg of omalizumab; Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.	Drug: 15mg/kg omalizumab injection; 15mg/kg of omalizumab; Other Names: Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants that tolerate the 600 mg dose after treatment.	The primary analysis of outcome is on the proportion of subjects tolerating at least 600 mg at the post-treatment OFC in either group against the expected outcome without treatment based on OUTMATCH data.	16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other measures of omalizumab treatment effect on food allergy	Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● The proportion of participants that tolerate a single dose 1000 mg allergen	16 Weeks
Other measures of omalizumab treatment effect on food allergy	Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● The proportion of participants that tolerate a single dose 2000 mg allergen	16 Weeks
Other measures of omalizumab treatment effect on food allergy	Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● The proportion of participants that tolerate two doses of 2000 mg allergen	16 Weeks
Other measures of omalizumab treatment effect on food allergy	Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● Reaction severity of positive post treatment reactions using the CoFAR grading scale ranging from 1 (mild) to 5 (death)	16 Weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Wayne Shreffler, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: omalizumab
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Anti-Idiotypic; Omalizumab
• Other Study ID Numbers: 2025P000538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No