Omalizumab Weight-Based Dosing Efficacy Trial

Phase 2

Not yet recruiting

• Conditions: Allergies; Food Allergy
• Interventions: Drug: 5mg/kg omalizumab injection; Drug: 15mg/kg omalizumab injection

• Registration Number: NCT06943534
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-04-28
• Primary Completion: 2027-05-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients Receiving 5mg/kg of omalizumab	5mg/kg omalizumab injection	Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.
Patients Receiving 15mg/kg of omalizumab	15mg/kg omalizumab injection	Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of participants that tolerate the 600 mg dose after treatment.	16 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Other measures of omalizumab treatment effect on food allergy	16 Weeks	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)

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States