Omalizumab Weight-Based Dosing Efficacy Trial

NCT06943534 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025P000538
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Allergies; Food Allergy

Keywords

omalizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Other measures of omalizumab treatment effect on food allergy

  16 Weeks

• Other measures of omalizumab treatment effect on food allergy

  16 Weeks

• Other measures of omalizumab treatment effect on food allergy

  16 Weeks

• Other measures of omalizumab treatment effect on food allergy

  16 Weeks

Study Arms (2)

Patients Receiving 5mg/kg of omalizumab

ACTIVE COMPARATOR

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

Patients Receiving 15mg/kg of omalizumab

ACTIVE COMPARATOR

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

Interventions

5mg/kg omalizumab injection DRUG

5mg/kg of omalizumab

Also known as: Xolair

Patients Receiving 5mg/kg of omalizumab

15mg/kg omalizumab injection DRUG

15mg/kg of omalizumab

Also known as: Xolair

Patients Receiving 15mg/kg of omalizumab

Eligibility Criteria

• Age: 1 Year - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Wayne Shreffler, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannat Gill

CONTACT

617-643-8683; Jgill@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 24, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)