Trial · NCT02626611
Multi Immunotherapy to Test Tolerance and Xolair
NCT02626611, Phase 2, Completed, Kari Christine Nadeau; results first posted 2017-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi Immunotherapy to Test Tolerance and Xolair. Trials, record NCT02626611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02626611
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi Immunotherapy to Test Tolerance and Xolair
- NCT number
- NCT02626611
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Kari Christine Nadeau
- Conditions
- Food Allergy
- Interventions
- Omalizumab, Food Flour Buildup
- First posted
- 2015-12-10
- Last updated
- 2017-12-18
- Results first posted
- 2017-12-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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. |
| Secondary | The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported. | 36 weeks | 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) . |
| Secondary | 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. | 36 weeks | 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. |
| Secondary | 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. | 36 weeks | 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. |
| Secondary | 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. | 36 weeks | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 36 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported. | 36 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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. | 36 weeks | Number of participants analyzed reflects only those participants with 3 or more food allergies. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | 36 weeks | Number of participants analyzed reflects only those participants with 4 or more food allergies | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | 36 weeks | Number of participants analyzed reflects only those participants with 5 or more food allergies | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Placebo | 11 | Participants | ||
| 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. | Low Dose Food | 17 | Participants | ||
| 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. | High Dose Food | 17 | Participants | ||
| The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported. | Placebo | 11 | Participants | ||
| The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported. | Low Dose Food | 17 | Participants | ||
| The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported. | High Dose Food | 17 | Participants | ||
| 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. | Placebo | 8 | Participants | ||
| 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. | Low Dose Food | 12 | Participants | ||
| 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. | High Dose Food | 13 | Participants | ||
| 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. | Placebo | 3 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | STARTED | Low Dose Food | 21 | |
| Overall Study | STARTED | High Dose Food | 19 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | Low Dose Food | 20 | |
| Overall Study | COMPLETED | High Dose Food | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Low Dose Food | 1 | |
| Overall Study | NOT COMPLETED | High Dose Food | 3 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | abdominal pain | Gastrointestinal disorders | All Participants Prior to Active Phase | 1 | 70 | |
| serious | abdominal pain | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| serious | abdominal pain | Gastrointestinal disorders | Low Dose Food | 0 | 21 | 0 |
| serious | abdominal pain | Gastrointestinal disorders | High Dose Food | 0 | 19 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants Prior to Active Phase | 0 | 70 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, all-cause mortality | Low Dose Food | 0 | 21 |
| Total, all-cause mortality | High Dose Food | 0 | 19 |
| Total, other adverse events | All Participants Prior to Active Phase | 0 | 70 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, other adverse events | Low Dose Food | 0 | 21 |
| Total, other adverse events | High Dose Food | 0 | 19 |
| Total, serious adverse events | All Participants Prior to Active Phase | 1 | 70 |
| Total, serious adverse events | Placebo | 0 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31193674 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02626611
GET https://conductscience.org/api/trials/v1/NCT02626611/registered