NCT06943534

Omalizumab Weight-Based Dosing Efficacy Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	5mg/kg omalizumab injection	5mg/kg of omalizumab
DRUG	15mg/kg omalizumab injection	15mg/kg of omalizumab

Timeline

• Start date: 2025-07-03
• Primary completion: 2027-05-01
• Completion: 2028-04-01
• First posted: 2025-04-24
• Last updated: 2026-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study