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NCT02643862 · ClinicalTrials.gov registry record · Phase 1
Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02643862: Completed Phase 1 study, sponsored by Stanford University.
NCT02643862 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02643862, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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). 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\*.
Primary Outcome
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%)
Interventions
- DRUG Placebo
- DRUG Xolair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-03-18 |
| Est. Completion | 2016-08-20 |
| Phase | Phase 1 |
What the finished NCT02643862 record still lists
NCT02643862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02643862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02643862 about?
NCT02643862 is a clinical study titled "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...
What is the current status of trial NCT02643862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2015-03-18. Estimated completion is 2016-08-20.
What interventions are being tested in trial NCT02643862?
The interventions under investigation include: Placebo (DRUG), Xolair (DRUG).
Who is sponsoring clinical trial NCT02643862?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02643862's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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