Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
ConditionFood Allergy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-30
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 1 to 30 years.
Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic.
Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control.
Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dose of ≤2043 mg) prior to starting omalizumab (using incremental doses of 3, 10, 30, 100, 300, 600, 1000 mg).
Disqualifiers
Clinically significant laboratory abnormalities in the past 6 months.
Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab
Poorly controlled or severe asthma/wheezing at screening
History of severe anaphylaxis to the participant-specific food that will be used in this study, defined as neurological compromise or requiring intubation.
Trial design
Design model
Single group
Treatments tested in this trial
Omalizumab
DrugPrior 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: omalizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 omalizumabSecondary outcomes
1
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 omalizumab2
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 omalizumabOther outcomes
1
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 omalizumabSponsors and contacts
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Source ClinicalTrials.gov
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