A Phase 4 interventional study of Omalizumab in Food Allergy, sponsored by Johns Hopkins University. Not yet recruiting at 1 site in United States. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Treatment
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:
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:
Exclusion Criteria:
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.
Drug: Omalizumab
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.
Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge.
The pre-specified thresholds for response is defined as the ability to consume at least two more incremental doses of food protein during post-treatment oral food challenge (using incremental doses of 3, 10, 30, 100, 300, 600, 1000, 2000, 2000, and 2000 mg), than during the baseline oral food challenge. First post-treatment oral food challenge conducted between ≥14 and ≤35 days after starting omalizumab (after one or two doses of omalizumab depending on whether the participant is receiving omalizumab every 2 or 4 weeks).
Time frame: Between ≥14 and ≤35 days after starting omalizumab
The absolute change in oral food challenge threshold between baseline and the first post-treatment oral food challenge.
Baseline oral food challenge conducted prior to starting omalizumab. First post-treatment oral food challenge conducted at ≥14 and ≤35 days after starting of omalizumab.
Time frame: Baseline, between ≥14 and ≤35 days after starting omalizumab
The absolute change in oral food challenge threshold between the first and second post-treatment oral food challenges.
First post-treatment oral food challenge conducted at ≥14 and ≤35 days after starting of omalizumab. Second post-treatment oral food challenge conducted between 4 to 6 months after starting omalizumab.
Time frame: between ≥14 and ≤35 days after starting omalizumab, 4-6 months after starting omalizumab
Association between oral food challenge outcomes and biomarkers including skin prick testing, allergen-specific IgE, total IgE, and free total IgE.
Time frame: At baseline, between ≥14 and ≤35 days starting omalizumab, and 4 to 6 months after starting omalizumab
Plan to share: No — There are no plans to share individual participant data.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University