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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06934200
Phase
PHASE2
Status
Recruiting
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Conditions

  • Food Hypersensitivity

Eligibility Criteria

Sex
ALL
Age
1 Year - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
Jun 2026
Primary completion
Apr 15, 2027
Completion
Oct 15, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Treatment with omalizumab
    This is an open label study of omalizumab with no placebo. Participants who meet study inclusion criteria and are enrolled in the study will receive omalizumab. The dose of omalizumab will be based on participant's weight.

Primary Outcome Measure

Number of participants without dose limiting symptoms [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21287
Robert+ Wood, MD
[email protected]
410-955-5883
Kim Mudd, RN
[email protected]
410-502-1711

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Johns Hopkins· Baltimore, MD

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