Food AllergyPhase 2M-TAXNCT02626611

Multi Immunotherapy to Test Tolerance and Xolair

A Phase 2 study testing Omalizumab and Food Flour Buildup in people with Food Allergy, run by Kari Christine Nadeau at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 4 to 55 years
Conditions the study is for: Food Allergy
What is being tested?: Omalizumab and Food Flour Buildup
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 7 sitesUnited States
Study dates: Dec 2015to 16 Nov 2016
Phase: Phase 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
Positive skin prick test result greater than or equal to 6 mm wheal diameter to each allergen OR
ImmunoCAP Immunoglobulin E (IgE) level >4 kilo Unit/Liter 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

Show all 11Show fewer

If female, must have a negative urine pregnancy test on the same day (using a Clinical Laboratory Improvement Amendment (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 >2,000 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

Show all 27Show fewer

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 betablockers (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 Oral Immunotherapy 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, nontraditional forms of allergen immunotherapy (e.g., oral or sublingual)
Severe asthma (2007 National Heart Lung and Blood Institute (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:
Forced Expiratory Volume at one second (FEV1) < 80% of predicted, or FEV1/Forced Vital Capacity (FVC) < 75%, with or without controller medications (only for age 6 or greater and able to do spirometry) or
Inhaled Corticosteroid (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 (Intravenous (IV), Intramuscular (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 Oral Food Challenges (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

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Lurie Children's Hospital, Northwestern University
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Sean N. Parker Center for Allergy Research at Stanford University
Mountain View, California, 94040
Mt. Sinai, Icahn School of Medicine
New York, New York, 10029
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Northwest Asthma & Allergy Center
Seattle, Washington, 98115

Other trials in United States

About this study

Official title: A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Tolerance M-TAX Study

This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted at multiple centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in Investigational New Drug (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens will be introduced in a rush desensitization day at week 8. Subjects will return to clinic to escalate the dose of their allergens until 2,000mg protein of each allergen is reached Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to one of three double blinded arms: Arm A- continue with current dose (2000 mg each food allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to each allergen at week 36. The final challenge of week 36 will be the final end of study visit.

Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects and their parents/guardians will receive extensive education on food allergy reactions and medication use.

Read the detailed description

The investigators will enroll multi food allergic subjects (4-55 years of age) with proven multi food allergies. The investigators anticipate enrolling 70 subjects with multi food allergies at more than one site. Subjects must have food specific Immunoglobulin E >4 kilo Units/Liter for each allergen or a skin test reactivity to each food allergen greater than or equal to 6mm wheal diameter. In addition, subjects must have a total Immunoglobulin E <2,000 kilo Units/Liter, a clinical reaction during a double blind placebo controlled food challenge (DBPCFC) with food protein/powder to establish sensitivity to given food protein/powder (pecan, milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut, hazelnut, shrimp, cod, salmon) and no clinical reaction during placebo (oat) as per Chemistry Manufacturing and Control section of Investigational New Drug.

Each subject is planned to be enrolled in the active phase of the study for 36 weeks.

Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations.

Omalizumab is approved by the European Medicines Agency (European FDA) for patients with severe asthma >6 years of age, and by the US FDA for patients >12 years of age. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.

Conditions: Food Allergy
Being tested: Omalizumab, Food Flour Buildup
Medical subject headings: Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmalizumabDrug
Also called Xolair
Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.
Food Flour BuildupDrug
Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized.

Study groups in NCT02626611
Study group	Role	What they receive
Placebo	Placebo comparator	Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints. Receives: Drug: Omalizumab; Drug: Food Flour Buildup
Low Dose Food	Active comparator	Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints. Receives: Drug: Omalizumab; Drug: Food Flour Buildup
High Dose Food	Active comparator	Xolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints. Receives: Drug: Omalizumab; Drug: Food Flour Buildup

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported.
Number of FA participants who pass a DBPCFC to 2,000 mg each of 2 allergens (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.
Measured: 36 weeks

Secondary outcomes (4)

The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported.
Number of FA participants who pass a DBPCFC to (4,000 mg each of 2 allergens at week 36) (i.e. no reaction of grade 1 or more according to Bock's criteria) .
Measured: 36 weeks
The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 3 Allergens (When Applicable) Separately at Week 36, Will be Reported.
Number of FA participants who pass a DBPCFC to 2,000 mg each of 3 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.
Measured: 36 weeks
The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 4 Allergens (When Applicable) Separately at Week 36, Will be Reported.
Number of FA participants who pass a DBPCFC to 2,000 mg each of 4 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.
Measured: 36 weeks
The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 5 Allergens (When Applicable) Separately at Week 36, Will be Reported.
Number of FA participants who pass a DBPCFC to 2,000 mg each of 5 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201516 Nov 2016

First posted10 Dec 2015 (estimated)
Study startDec 2015
Primary completion16 Nov 2016
Study completion16 Nov 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 (1)Papers the sponsor has linked to this study.
Other trials for Food AllergyStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02626611
Sponsor's protocol ID: 28942
Acronym: M-TAX
Status last verified: Dec 2017
First submitted: 24 Nov 2015
Last updated: 18 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Andorf S, Purington N, Kumar D, Long A, O'Laughlin KL, Sicherer S, Sampson H, Cianferoni A, Whitehorn TB, Petroni D, Makhija M, Robison RG, Lierl M, Logsdon S, Desai M, Galli SJ, Rael E, Assa'ad A, Chinthrajah S, Pongracic J, Spergel JM, Tam J, Tilles S, Wang J, Nadeau K. A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued vs Discontinued Dosing in Multifood Allergic Individuals. EClinicalMedicine. 2019 Jan 21;7:27-38. doi: 10.1016/j.eclinm.2018.12.006. eCollection 2019 Jan.
PubMed 31193674

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
RecruitingPhase 4
Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
Food Allergy
Active, not recruiting
Slow Multiallergen Oral Immunotherapy in Young Children
Food Allergy, Oral Immunotherapy for Food Allergy
Not yet recruiting
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
Food Allergy in Children

All Food Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Tolerance M-TAX Study
ClinicalTrials.gov ID: NCT02626611
Acronym / sponsor ID: M-TAX / 28942
Conditions: Food Allergy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Kari Christine NadeauUniversity, hospital or other
Collaborators: Icahn School of Medicine at Mount Sinai, Children's Hospital of Philadelphia, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital Medical Center, Cincinnati, Children's Hospital Los Angeles, University of Washington
Study start: Dec 2015 (actual)
Primary completion: 16 Nov 2016 (actual)
Study completion: 16 Nov 2016 (actual)
First posted: 10 Dec 2015 (estimated)
Results: Posted 18 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Each subject is planned to be enrolled in the active phase of the study for 36 weeks.

Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Omalizumab, Drug: Food Flour BuildupXolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.
Low Dose Food	Active comparator	Drug: Omalizumab, Drug: Food Flour BuildupXolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.
High Dose Food	Active comparator	Drug: Omalizumab, Drug: Food Flour BuildupXolair will be administered in week 0 through 16 of the study. Starting at week 8, food doses will be serially increased, per protocol, to up to 2000 milligrams per food. At week 30, the cohort will be randomized into 3 groups (placebo, low dose food, and high dose food). Participants will continue on this dose for 6 weeks. The oat placebo food, will be compared to high dose (2000 milligrams or low dose 300 milligrams food immunotherapy). At week 36 a food challenge will be performed to assess study endpoints.

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
Positive skin prick test result greater than or equal to 6 mm wheal diameter to each allergen OR
ImmunoCAP Immunoglobulin E (IgE) level >4 kilo Unit/Liter 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 (27 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 >2,000 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
OmalizumabAlso: XolairOmalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.	Drug	High Dose Food, Low Dose Food, Placebo
Food Flour BuildupFood flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized.	Drug	High Dose Food, Low Dose Food, Placebo

Primary outcome

The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported.
Time frame: 36 weeks
Number of FA participants who pass a DBPCFC to 2,000 mg each of 2 allergens (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.

4 secondary outcomes

The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported.
Time frame: 36 weeks
The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 3 Allergens (When Applicable) Separately at Week 36, Will be Reported.
Time frame: 36 weeks
The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 4 Allergens (When Applicable) Separately at Week 36, Will be Reported.
Time frame: 36 weeks
The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 5 Allergens (When Applicable) Separately at Week 36, Will be Reported.
Time frame: 36 weeks

Results and safety

Results posted to the registry on 18 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	20	16
Low Dose Food	21	20
High Dose Food	19	16

Primary outcome: The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported.

Time frame: 36 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 20	Low Dose Food n = 21	High Dose Food n = 19
Value	11	17	17

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants Prior to Active Phase	1 of 70 (1.4%)	0 of 70 (0%)	0 of 70
Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Low Dose Food	0 of 21 (0%)	0 of 21 (0%)	0 of 21
High Dose Food	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31193674Andorf S, Purington N, Kumar D, Long A, O'Laughlin KL, Sicherer S, Sampson H, Cianferoni A, Whitehorn TB, Petroni D, Makhija M, Robison RG, Lierl M, Logsdon S, Desai M, Galli SJ, Rael E, Assa'ad A, Chinthrajah S, Pongracic J, Spergel JM, Tam J, Tilles S, Wang J, Nadeau K. A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued vs Discontinued Dosing in Multifood Allergic Individuals. EClinicalMedicine. 2019 Jan 21;7:27-38. doi: 10.1016/j.eclinm.2018.12.006. eCollection 2019 Jan.

Related trials for Food Allergy

RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
RecruitingPhase 4
Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
Food Allergy
Active, not recruiting
Slow Multiallergen Oral Immunotherapy in Young Children
Food Allergy, Oral Immunotherapy for Food Allergy
Not yet recruiting
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
Food Allergy in Children

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.

Nadeau C Nadeau, MD PhD principal investigator

Stanford University

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omalizumab and Food Flour Buildup in people with Food Allergy, run by Kari Christine Nadeau at 7 sites 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 27 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 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 phase mean?

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 18 Dec 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?

The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported. (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 NCT02626611, which also lists 1 linked publication.

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 18 Dec 2017.