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Multi Immunotherapy to Test Tolerance and Xolair
NCT02626611 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Omalizumab
- DRUG Food Flour Buildup
Study Locations (7)
California
- Children's Hospital of Los Angeles — Los Angeles
- Sean N. Parker Center for Allergy Research at Stanford University — Mountain View
Illinois
- Lurie Children's Hospital, Northwestern University — Chicago
New York
- Mt. Sinai, Icahn School of Medicine — New York
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Washington
- Northwest Asthma & Allergy Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-11-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02626611
The ClinicalTrials.gov registry entry for NCT02626611 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kari Christine Nadeau, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Food Allergy appearing as the primary indexed condition, and to 2 interventions — of which Omalizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02626611 reports 7 study locations spanning 6 distinct geographic areas — top geographies include California, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02626611 about?
NCT02626611 is a clinical study titled "Multi Immunotherapy to Test Tolerance and Xolair". 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 wil...
What is the current status of trial NCT02626611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2015-12. Estimated completion is 2016-11-16.
What conditions does trial NCT02626611 study?
This clinical trial studies the following conditions: Food Allergy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02626611?
The interventions under investigation include: Omalizumab (DRUG), Food Flour Buildup (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02626611?
This trial is sponsored by Kari Christine Nadeau, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02626611 being conducted?
This trial has 7 study locations across California, Illinois, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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