NCT Number: NCT01157117
Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products.
Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop "tolerance," which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair® (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.
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Notify Me7 year–35 year
All sexes
Interventional
Phase 2
Stanford University School of Medicine, Stanford, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Active Treatment Subjects:
Control Subjects:
Exclusion criteria
Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight).
Other names: Placebo for Xolair
Omalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight.
Other names: Xolair
Milk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed.
Time frame: Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group
Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.
Time frame: Baseline to completion of Escalation Phase at 22 to 40 weeks
Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.
Time frame: After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30
Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.
Time frame: Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)
Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.
Time frame: Baseline to completion of Escalation Phase at 22 to 40 weeks
Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.
Time frame: Month 28
Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.
Time frame: Baseline to completion of Escalation Phase at 22 to 40 weeks
Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.
Time frame: Month 32
A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.
Time frame: Month 32
The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.
Time frame: Month 32
Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.
Time frame: Month 38
The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.
Time frame: Month 38
Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.
Time frame: Month 32
Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.
Time frame: Month 38
Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.
Hugh A Sampson, MD
Other
Oral Immunotherapy Combined With Humanized Monoclonal Anti-IgE Antibody Xolair® (Omalizumab)in the Treatment of Cow's Milk Allergy
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