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

ConditionFood Hypersensitivity

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age1-55

SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 1 to 55 years

A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)

Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods

A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above

Disqualifiers

Clinically significant laboratory abnormalities at screening.

Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.

Poorly controlled or severe asthma/wheezing at screening

History of severe anaphylaxis to participant-specific foods 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
Drug
omalizumab injections

Treatment groups

32 Participants

are divided into 1 treatment group

Group A: Treatment with omalizumabOther 1 intervention

Trial outcomes

Primary outcomes

Number of participants without dose limiting symptoms

Consumption of a single dose of 600mg or more of food protein without dose-limiting symptoms during the week 24 Double-blind, Placebo-controlled, Food Challenge

Time frame

24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov

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