NCT06934200

Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 1 Year – 55 Years
• Healthy volunteers: Not accepted

Summary

In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.

Conditions

• Food Hypersensitivity

Interventions

Type	Name	Description
DRUG	Omalizumab	omalizumab injections

Timeline

• Start date: 2025-05-19
• Primary completion: 2027-04-15
• Completion: 2027-10-15
• First posted: 2025-04-18
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study