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NCT02626611 · ClinicalTrials.gov registry record · Phase 2
Multi Immunotherapy to Test Tolerance and Xolair
A Phase 2 study of Food Allergy, sponsored by Kari Christine Nadeau.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 7
- Study locations
NCT02626611 is a Phase 2 study of Food Allergy that has completed, run by Kari Christine Nadeau. The registered enrollment target is 70 participants, below the 960-participant average among 17 other Food Allergy trials with a reported enrollment target (93% lower). The trial reports 7 study locations across 6 states.
The verdict
NCT02626611, a Phase 2 study of Food Allergy, has completed, sponsored by Kari Christine Nadeau.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 7
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 960-participant average among 17 other Food Allergy trials with a reported enrollment target (93% lower). The listed sponsor is Kari Christine Nadeau, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT02626611 reports 7 study locations spanning 6 distinct geographic areas - top geographies include California, Illinois, New York.
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.
What interventions are being tested in trial NCT02626611?
The interventions under investigation include: Omalizumab (DRUG), Food Flour Buildup (DRUG).
Who is sponsoring clinical trial NCT02626611?
This trial is sponsored by Kari Christine Nadeau, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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