Trial · NCT04045301
Omalizumab to Accelerate a Symptom-driven Multi-food OIT
NCT04045301, Phase 2, Completed, Philippe Bégin
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Omalizumab to Accelerate a Symptom-driven Multi-food OIT. Trials, record NCT04045301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04045301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Omalizumab to Accelerate a Symptom-driven Multi-food OIT
- NCT number
- NCT04045301
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Philippe Bégin
- Conditions
- Food IgE-mediated Allergy, Immunotherapy, Omalizumab, Physiological Effects of Drugs
- Interventions
- Omalizumab 16mg/kg, Omalizumab 8mg/kg, Placebo, Multi-food oral immunotherapy (OIT)
- First posted
- 2019-08-05
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol. | Assessed up to 52 weeks after IFE | Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein |
| Secondary | Change in reactivity threshold to food treatment mix after pre-treatment with study drug. | Measured 8 weeks after starting investigational product | Measured as the amount of food allergen eliciting an objective allergic reaction on double-blinded oral food challenge or initial food escalation. |
| Secondary | Average up-dosing speed while on study drug. | From week 0 to week 12 post IFE | Average of (log of escalation %)/(days since last escalation) for all escalation visits while on study drug |
| Secondary | Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial. | For one year following IFE | AEs will be captured using the daily dosing diary throughout the trial, including during maintenance. Any systemic reaction having occurred since the last visit will be reviewed and graded by the investigator according to the CoFAR grading system. |
| Secondary | Rate of treatment failure | At any time during the 12-month OIT phase | Subject which stop daily ingestion of food treatment mix, prior to achieving study maintenance dose, for a period of 14 days or more |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32328115 | 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/NCT04045301
GET https://conductscience.org/api/trials/v1/NCT04045301/registered