Omalizumab Weight-Based Dosing Efficacy Trial

NCT ID: NCT06943534

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2028-04-01

Brief Summary

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

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.

Conditions

Allergies; Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

5mg/kg omalizumab injection

Intervention Type: DRUG

5mg/kg of omalizumab

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.

Group Type: ACTIVE_COMPARATOR

15mg/kg omalizumab injection

Intervention Type: DRUG

15mg/kg of omalizumab

Interventions

5mg/kg omalizumab injection

5mg/kg of omalizumab

Intervention Type: DRUG

15mg/kg omalizumab injection

15mg/kg of omalizumab

Intervention Type: DRUG

Other Intervention Names

Xolair; Xolair

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wayne G. Shreffler, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne Shreffler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

University of Texas Southwestern

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jannat Gill

Role: CONTACT

Jgill@mgh.harvard.edu

617-643-8683

Facility Contacts

Jannat Gill

Role: primary

Jgill0@mgh.harvard.edu

614-643-8683

Lauren Herlihy

Role: primary

lherlihy@unc.edu

Dolores Santoyo

Role: primary

Dolores.Santoyo@UTSouthwestern.edu

Other Identifiers

2025P000538

Identifier Type: -

Identifier Source: org_study_id