Trial · NCT03181009
Multi OIT to Test Immune Markers After Minimum Maintenance Dose
NCT03181009, Phase 2, Completed, Andrew Long, PharmD; results first posted 2019-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi OIT to Test Immune Markers After Minimum Maintenance Dose. Trials, record NCT03181009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03181009
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi OIT to Test Immune Markers After Minimum Maintenance Dose
- NCT number
- NCT03181009
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Andrew Long, PharmD
- Conditions
- Food Allergy
- Interventions
- Omalizumab, Food Flour Allergens
- First posted
- 2017-06-08
- Last updated
- 2026-04-27
- Results first posted
- 2019-09-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Allergen-specific Serum IgG4 and IgE | 18 weeks | Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Allergen-specific Serum IgG4 and IgE | 18 weeks | Total serum IgE (kU/L) | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Allergen-specific Serum IgG4 and IgE | Group A (300 mg Maintenance Dose) | 578.5 | Full Range 64.6 to 6538 | Total serum IgE (kU/L) | |
| Change in Allergen-specific Serum IgG4 and IgE | Group B (1200 Maintenance Dose) | 738.5 | Full Range 61.0 to 4367 | Total serum IgE (kU/L) |
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 | Group A (300 mg Maintenance Dose) | 30 | |
| Overall Study | STARTED | Group B (1200 Maintenance Dose) | 30 | |
| Overall Study | COMPLETED | Group A (300 mg Maintenance Dose) | 30 | |
| Overall Study | COMPLETED | Group B (1200 Maintenance Dose) | 28 | |
| Overall Study | NOT COMPLETED | Group A (300 mg Maintenance Dose) | 0 | |
| Overall Study | NOT COMPLETED | Group B (1200 Maintenance Dose) | 2 |
Source ClinicalTrials.gov
Adverse events8
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 | Abdominal pain | Gastrointestinal disorders | Group A (300 mg Maintenance Dose) | 14 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Group B (1200 Maintenance Dose) | 12 | 30 | |
| other | chills, facial edema, fatigue | General disorders | Group A (300 mg Maintenance Dose) | 3 | 30 | |
| other | chills, facial edema, fatigue | General disorders | Group B (1200 Maintenance Dose) | 12 | 30 | |
| other | cough, sneezing | Respiratory, thoracic and mediastinal disorders | Group A (300 mg Maintenance Dose) | 1 | 30 | |
| other | cough, sneezing | Respiratory, thoracic and mediastinal disorders | Group B (1200 Maintenance Dose) | 1 | 30 | |
| other | pruritus, rash | Skin and subcutaneous tissue disorders | Group A (300 mg Maintenance Dose) | 1 | 30 | |
| other | pruritus, rash | Skin and subcutaneous tissue disorders | Group B (1200 Maintenance Dose) | 1 | 30 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A (300 mg Maintenance Dose) | 0 | 30 |
| Total, all-cause mortality | Group B (1200 Maintenance Dose) | 0 | 30 |
| Total, other adverse events | Group A (300 mg Maintenance Dose) | 19 | 30 |
| Total, other adverse events | Group B (1200 Maintenance Dose) | 16 | 30 |
| Total, serious adverse events | Group A (300 mg Maintenance Dose) | 0 | 30 |
| Total, serious adverse events | Group B (1200 Maintenance Dose) | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35014049 | RESULT |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A (300 mg Maintenance Dose) vs Group B (1200 Maintenance Dose): deaths from any cause | Trial comparisons |
| Group A (300 mg Maintenance Dose) vs Group B (1200 Maintenance Dose): 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/NCT03181009
GET https://conductscience.org/api/trials/v1/NCT03181009/registered