Food AllergyPhase 1/2MAP-XNCT02643862
Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
A Phase 1/2 study testing Xolair in people with Food Allergy, run by Stanford University at 1 site in United States.
Trial summary
This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). Read more about this study
- Who is it for?
- Ages 4 to 55 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Xolair
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2015to 20 Aug 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.
- Age 4 to 55 years with moderate to severe allergy to milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut
- ositive skin prick test result greater than or equal to 6 mm wheal diameter to each allergen OR
- ImmunoCAP IgE level >4kU/L for each allergen and
- A clinical reaction during a DBPCFC to small doses of food defined as < dose of 500 mg food protein
- No clinical reaction observed during the placebo (oat) challenge and
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- If female, must have a negative urine pregnancy test on the same day (using a CLIA approved urine test)
- If female, of child-bearing potential, must agree to be compliant with a medically-approved method of contraception (please see Pregnancy section under Patient Disposition in this protocol)
- Plan to remain in the study area of the research center during the trial
- Be trained on the proper use of the Epinephrine autoinjector
- Avoid open or blinded food challenges to other allergens outside this study
Who cannot join
- Inability or unwillingness of a participant/parent/guardian to give written informed consent or comply with study protocol
- History of cardiovascular disease
- History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the participant's health or safety in this study or the participant's ability to comply with the study protocol
- A total IgE at screening of >1,500 kU/L
- Previous adverse reaction to Xolair
- A history of severe anaphylaxis (defined as requiring intubation or admission to an ICU) to food allergens that will be used in this study
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- Unstable angina, significant arrhythmia, uncontrolled hypertension, current smokers, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the participant.
- Current use of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical)
- Routine use of medication that could induce adverse gastrointestinal reactions during the study
- Refusing to sign the Epinephrine autoinjector Training Form
- Pregnant or breast feeding women
- A history of oat allergy (since oat is the placebo agent in the DBPCFC), or an objective reaction to the screening DBPCFC to oat
- Unwilling to avoid all food allergen-containing items except those given as part of the OIT as well as any other food allergens you are allergic to that are not included in the 10 foods listed in the study
- Concurrent/prior use of immunomodulatory therapy (within 1 month) ie, omalizumab, non-traditional forms of allergen immunotherapy (e.g., oral or sublingual)
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6) at time of enrollment
- Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4) at time of enrollment with any of the following criteria met:
- FEV1 < 80% of predicted, or FEV1/FVC < 75%, with or without controller medications (only for age 6 or greater and able to do spirometry) or
- ICS dosing of > 220 mcg daily fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
- 1 hospitalization in the past year for asthma or
- ER visit for asthma within the past six months
- Use of steroid medications (IV, IM or oral) in the following manners
- history of daily oral steroid dosing for >1 month during the past year or
- steroid burst course ( 5 or more days) of 1 mg/kg prednisone) course in the past 3 months or
- >2 steroid burst courses in the past year
- Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and/or non-atopic disease within 90 days preceding rush desensitization at week 8or at any time .
- Inability to discontinue antihistamines for the initial day of escalation, skin testing or OFCs
- Use of investigational drugs within 24 weeks of participation
- Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sean N Parker Allergy Reseach Center at Stanford University
Mountain View, California, 94040
About this study
Official title: Randomized, Controlled, Blinded, Pilot Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). 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*.
Read the detailed description
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.
- Conditions
- Food Allergy
- Being tested
- Xolair, Placebo
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairDrug
Also called omalizumab
Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| xolair | Active comparator | Pts will be randomized to receive xolair at a 3 active:1 placebo ratio Receives: Drug: Xolair |
| Placebo | Placebo comparator | This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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%)
Measured: 36 weeks
Secondary outcomes (1)
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
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%)
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start18 Mar 2015
- Primary completion20 Aug 2016
- Study completion20 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Christine Nadeau, Stanford University
- Investigators
- Kari Nadeau, MD PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643862
- Sponsor's protocol ID
- 123
- Other IDs
- U19AI104209
- Acronym
- MAP-X
- Status last verified
- Dec 2017
- First submitted
- 24 Nov 2015
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Manohar M, Dunham D, Gupta S, Yan Z, Zhang W, Minnicozzi S, Kirkey M, Bunning B, Roy Chowdhury R, Galli SJ, Boyd SD, Kost LE, Chinthrajah RS, Desai M, Oettgen HC, Maecker HT, Yu W, DeKruyff RH, Andorf S, Nadeau KC. Immune changes beyond Th2 pathways during rapid multifood immunotherapy enabled with omalizumab. Allergy. 2021 Sep;76(9):2809-2826. doi: 10.1111/all.14833. Epub 2021 May 29.
PubMed 33782956Andorf S, Purington N, Block WM, Long AJ, Tupa D, Brittain E, Rudman Spergel A, Desai M, Galli SJ, Nadeau KC, Chinthrajah RS. Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2018 Feb;3(2):85-94. doi: 10.1016/S2468-1253(17)30392-8. Epub 2017 Dec 12.
PubMed 29242014
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Blinded, Pilot Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
- ClinicalTrials.gov ID
- NCT02643862
- Acronym / sponsor ID
- MAP-X / 123
- Conditions
- Food Allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 20 Aug 2016 (actual)
- Study completion
- 20 Aug 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 25 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). 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*.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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*.
| Arm | Type | Receives |
|---|---|---|
| xolair | Active comparator | Drug: XolairPts will be randomized to receive xolair at a 3 active:1 placebo ratio |
| Placebo | Placebo comparator | Drug: PlaceboThis is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair |
Who may qualify
- Ages
- 4 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Participant and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.
- Age 4 to 55 years with moderate to severe allergy to milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut
- ositive skin prick test result greater than or equal to 6 mm wheal diameter to each allergen OR
- ImmunoCAP IgE level >4kU/L for each allergen and
- A clinical reaction during a DBPCFC to small doses of food defined as < dose of 500 mg food protein
Key exclusion criteria (28 listed)
- Inability or unwillingness of a participant/parent/guardian to give written informed consent or comply with study protocol
- History of cardiovascular disease
- History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the participant's health or safety in this study or the participant's ability to comply with the study protocol
- A total IgE at screening of >1,500 kU/L
- Previous adverse reaction to Xolair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairAlso: omalizumabXolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria | Drug | xolair |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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%)
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33782956Manohar M, Dunham D, Gupta S, Yan Z, Zhang W, Minnicozzi S, Kirkey M, Bunning B, Roy Chowdhury R, Galli SJ, Boyd SD, Kost LE, Chinthrajah RS, Desai M, Oettgen HC, Maecker HT, Yu W, DeKruyff RH, Andorf S, Nadeau KC. Immune changes beyond Th2 pathways during rapid multifood immunotherapy enabled with omalizumab. Allergy. 2021 Sep;76(9):2809-2826. doi: 10.1111/all.14833. Epub 2021 May 29.
- Derived from this study: PubMed 29242014Andorf S, Purington N, Block WM, Long AJ, Tupa D, Brittain E, Rudman Spergel A, Desai M, Galli SJ, Nadeau KC, Chinthrajah RS. Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2018 Feb;3(2):85-94. doi: 10.1016/S2468-1253(17)30392-8. Epub 2017 Dec 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Nadeau, MD PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xolair in people with Food Allergy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643862, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.