Trial · NCT03679676
Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
NCT03679676, Phase 2, Completed, Stanford University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE). Trials, record NCT03679676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03679676
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
- NCT number
- NCT03679676
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Hypersensitivity, Food Allergy, Hypersensitivity, Food, Peanut Hypersensitivity, Peanut Allergy
- Interventions
- Omalizumab, Dupilumab, Placebo for Dupilumab, Placebo for Omalizumab
- First posted
- 2018-09-20
- Last updated
- 2026-05-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC) | 44 weeks | Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B. Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed. |
| Primary | The Success Rates of Passing a DBPCFC to Peanut and at Least One Other FA | 44 weeks | Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B. Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed. |
| Primary | The Success Rates of Passing a DBPCFC to Peanut and Two Other FAs | 44 weeks | Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B. Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed. |
| Secondary | Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of >=1,043 mg Protein to 1, 2, or 3 FAs When Applicable at Week 44 | 44 weeks | Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed. |
| Secondary | Proportion of Participants Who Successfully Pass DBPCFCs to a Cumulative Dose of ≥2,043 mg to 1, 2, or 3 FAs When Applicable at Week 32 | 32 weeks | Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed. |
| Secondary | Proportion of Participants Who Pass DBPCFCs for Each FA at a Cumulative Dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at Week 32 and/or Week 44. | week 32 and/or 44 | Outcome measures (rates) are presented as the percent of participants who passed, with the additional detail of the counts of participants who pass, and the participants who were analyzed. |
| Secondary | Proportion of Participants Who Have a 10-fold Change in the Cumulative Tolerance Dose for Each FA at Weeks 32 and/or Week 44, Compared to Baseline | Baseline and week 32 and/or 44 | Outcome measures (rates) are presented as the percent of participants who had a 10-fold change, with the additional detail of the counts of participants who had that change, and the participants who were analyzed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT03679676
GET https://conductscience.org/api/trials/v1/NCT03679676/registered