Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients (MAP-X)
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|ClinicalTrials.gov Identifier: NCT02643862|
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : October 25, 2017
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy||Drug: Xolair Drug: Placebo||Phase 1 Phase 2|
We will enroll multi food allergic participants (4-55 years of age) with proven "multi food allergies". We anticipate enrolling 60 participants with allergies to, at least two foods. Participants must have food specific IgE>4kU/L for each allergen or a skin test reactivity to each food allergen ≥ 6 mm wheal diameter. We have chosen criteria associated with a very low likelihood of natural loss of food allergy for the duration of this protocol. These values of specific IgE and SPT were chosen based on the opinions of 4 experts. Participants also must have a total IgE <1500kU/L, a clinical reaction during a double blind placebo controlled food challenge (DBPCFC) with food proteins/powders to establish sensitivity to given food proteins/powders (milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut, hazelnut) and no clinical reaction during placebo (oat) as per CMC section of IND.
Participants will undergo a rush desensitization day at week 8 to a maximum dose of 1,250 mg total protein. Participants will be ingesting either 2 to 5 food allergens, depending on their allergy screening. They will consume home doses for two weeks based on the these results and document reactions. Upon returning to the CFRU (Clinical Food Research Unit) two weeks later, a dose escalation will be attempted. This cycle will continue until the participant reaches a maximum dose of 2,000 mg protein daily of each food allergen (two to five food allergens to be ingested by the participant). No more than 5 allergens will be given.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||In a 3:1 ratio, 36* participants will receive Xolair for 16 weeks while 12* will receive corresponding placebo instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These 12 controls are not part of the randomization. The total number of participants randomized to the two arms is 48*.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Controlled, Blinded, Pilot Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients|
|Actual Study Start Date :||March 18, 2015|
|Actual Primary Completion Date :||August 20, 2016|
|Actual Study Completion Date :||August 20, 2016|
Active Comparator: xolair
Pts will be randomized to receive xolair at a 3 active:1 placebo ratio
Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
Other Name: omalizumab
Placebo Comparator: Placebo
This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair
- Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36 [ Time Frame: 36 weeks ]
Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36.
Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)
- Desensitization Measured to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36 [ Time Frame: 36 weeks ]
Proportion of FA participants who pass a DBPCFC to 4,000 mg each of 2 allergens at week 36.
Greater than 3 foods at 36 weeks for
Xolair: 21/26 (80.8%) Placebo: 2/7 (28.6%)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643862
|United States, California|
|Sean N Parker Allergy Reseach Center at Stanford University|
|Mountain View, California, United States, 94040|
|Study Director:||Kari Nadeau, MD PhD||Stanford University|