Trial · NCT02643862
Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
NCT02643862, Phase 1, Phase 2, Completed, Stanford University; results first posted 2017-10-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients. Trials, record NCT02643862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02643862
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
- NCT number
- NCT02643862
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Food Allergy
- Interventions
- Xolair, Placebo
- First posted
- 2015-12-31
- Last updated
- 2018-01-12
- Results first posted
- 2017-10-25
- Limitations and caveats
- The mechanistic 12 controls are not part of the randomization. The arms that are randomized are 48\*. Mechanistic controls did not undergo therapy.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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%) |
| Secondary | 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 | 36 weeks | 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%) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 36 weeks | this is an ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 36 weeks | We analyzed an ITT | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Xolair | 30 | Participants | ||
| 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 | Placebo | 4 | Participants | ||
| 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 | Xolair | 21 | Participants | ||
| 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 | Placebo | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xolair | 36 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Xolair | 36 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Xolair | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | urticaria | Skin and subcutaneous tissue disorders | Xolair | 33 | 36 | 106 |
| other | urticaria | Skin and subcutaneous tissue disorders | Placebo | 12 | 12 | 28 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xolair | 0 | 36 |
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, other adverse events | Xolair | 33 | 36 |
| Total, other adverse events | Placebo | 12 | 12 |
| Total, serious adverse events | Xolair | 0 | 36 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U19AI104209 | Integrated Genomic and Functional Studies of Immunotherapy for Multi-Food Allergy | GALLI, STEPHEN JOSEPH | STANFORD UNIVERSITY | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2013 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Xolair vs Placebo: 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 | Trial comparisons |
| Xolair vs Placebo: 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 | Trial comparisons |
| Xolair vs Placebo: deaths from any cause | Trial comparisons |
| Xolair vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02643862
GET https://conductscience.org/api/trials/v1/NCT02643862/registered