Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07845552
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Prior to starting omalizumab, participants will undergo a baseline oral food challenge. Participants will then initiate omalizumab treatment as prescribed by their doctor as part of routine clinical care. After 2 to 4 weeks of treatment (following one to two doses of omalizumab), participants will undergo a first post-treatment oral food challenge to assess treatment response. After 4 to 6 months of omalizumab treatment, participants will undergo a second post-treatment oral food challenge. The study will conclude following the second post-treatment oral food challenge.

Study Details

The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is: * Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy? Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment. Participants will: * Have a baseline food challenge before starting omalizumab. * Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care. * Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab. * Have skin prick testing and blood tests at study visits.

Key Dates

First listed
Sep 29, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

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

Arms

  • Experimental: omalizumab
    Omalizumab is approved by the FDA for the treatment of food allergy in patients aged 1 year and older. Omalizumab is administered as a subcutaneous injection at doses ranging from 75 mg to 600 mg every 2 or 4 weeks. Omalizumab treatment is not provided as part of this study. Participants will receive omalizumab treatment as part of their routine care for food allergy as prescribed by their doctor in the clinical setting.

Primary Outcome Measure

Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge. [ Time Frame: Between ≥14 and ≤35 days after starting omalizumab ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Kim Mudd
[email protected]
410-955-5883
Robert Wood, MD
[email protected]
410-955-5883
Robert Wood, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins Hospital· Baltimore, MD

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