Trial · NCT01157117
OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
NCT01157117, Phase 2, Completed, Hugh A Sampson, MD; results first posted 2016-04-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. OIT and Xolair® (Omalizumab) in Cow's Milk Allergy. Trials, record NCT01157117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01157117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
- NCT number
- NCT01157117
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Hugh A Sampson, MD
- Conditions
- Milk Allergy
- Interventions
- Placebo for omalizumab, Omalizumab, Milk powder
- First posted
- 2010-07-05
- Last updated
- 2020-08-14
- Results first posted
- 2016-04-06
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk | Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group | Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes. |
| Secondary | Incidence of Dosing Reactions to Milk OIT During the Escalation Phase | Baseline to completion of Escalation Phase at 22 to 40 weeks | Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase. |
| Secondary | Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase | After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30 | Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase. |
| Secondary | Incidence of Severe Hypersensitivity Reactions to Milk OIT | Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC) | Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction. |
| Secondary | Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT) | Baseline to completion of Escalation Phase at 22 to 40 weeks | Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days. |
| Secondary | Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk | Month 28 | Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes. |
| Secondary | Time to Maximum Tolerated Dose | Baseline to completion of Escalation Phase at 22 to 40 weeks | Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days. |
| Secondary | Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test | Month 32 | A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score. |
| Secondary | Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE) | Month 32 | The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment. |
| Secondary | Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4) | Month 32 | Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk | Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Percent of participants | NUMBER |
| SECONDARY | Incidence of Dosing Reactions to Milk OIT During the Escalation Phase | Baseline to completion of Escalation Phase at 22 to 40 weeks | Participants who received any milk OIT dosing during the Escalation Phase. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase | After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30 | Participants who received milk OIT dosing during the Maintenance Phase. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Severe Hypersensitivity Reactions to Milk OIT | Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC) | Participants who received milk OIT dosing. | percentage of participants | NUMBER |
| SECONDARY | Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT) | Baseline to completion of Escalation Phase at 22 to 40 weeks | Participants who received any milk OIT dosing | mg milk powder | MEAN |
| SECONDARY | Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk | Month 28 | Participants who received any study treatment | percentage of participants | NUMBER |
| SECONDARY | Time to Maximum Tolerated Dose | Baseline to completion of Escalation Phase at 22 to 40 weeks | Time to maximum tolerated dose could not be calculated because the maximum dose for the protocol was changed part way through the study after some subjects had already reached the maximum dose. | ||
| SECONDARY | Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test | Month 32 | All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed. | units on a scale | MEDIAN |
| SECONDARY | Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE) | Month 32 | All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported. | kUA/L | MEDIAN |
| SECONDARY | Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4) | Month 32 | All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported. | mgA/L | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk | Omalizumab/Milk OIT | 46.4 | Percent of participants | ||
| Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk | Placebo for Omalizumab/Milk OIT | 34.5 | Percent of participants | ||
| Incidence of Dosing Reactions to Milk OIT During the Escalation Phase | Omalizumab/Milk OIT | 81.5 | percentage of participants | ||
| Incidence of Dosing Reactions to Milk OIT During the Escalation Phase | Placebo for Omalizumab/Milk OIT | 96.4 | percentage of participants | ||
| Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase | Omalizumab/Milk OIT | 46.2 | percentage of participants | ||
| Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase | Placebo for Omalizumab/Milk OIT | 96.2 | percentage of participants | ||
| Incidence of Severe Hypersensitivity Reactions to Milk OIT | Omalizumab/Milk OIT | 0 | percentage of participants | ||
| Incidence of Severe Hypersensitivity Reactions to Milk OIT | Placebo for Omalizumab/Milk OIT | 0 | percentage of participants | ||
| Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT) | Omalizumab/Milk OIT | 9941.7 | Standard Deviation 2692.9 | mg milk powder | |
| Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT) | Placebo for Omalizumab/Milk OIT | 9174.0 | Standard Deviation 3344.6 | mg milk powder |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omalizumab/Milk OIT | 28 | |
| Overall Study | STARTED | Placebo for Omalizumab/Milk OIT | 29 | |
| Overall Study | STARTED | Untreated Control | 20 | |
| Overall Study | Began Omalizumab or Placebo Dosing | Omalizumab/Milk OIT | 27 | |
| Overall Study | Began Omalizumab or Placebo Dosing | Placebo for Omalizumab/Milk OIT | 28 | |
| Overall Study | Began Omalizumab or Placebo Dosing | Untreated Control | 0 | |
| Overall Study | Began Milk OIT Dosing at Month 4 | Omalizumab/Milk OIT | 27 | |
| Overall Study | Began Milk OIT Dosing at Month 4 | Placebo for Omalizumab/Milk OIT | 28 | |
| Overall Study | Began Milk OIT Dosing at Month 4 | Untreated Control | 0 | |
| Overall Study | Reached Milk OIT Maintenance Dosing | Omalizumab/Milk OIT | 26 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events195
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 | Ear Pruritus | Ear and labyrinth disorders | Omalizumab/Milk OIT | 1 | 27 | 1 |
| other | Ear Pruritus | Ear and labyrinth disorders | Placebo for Omalizumab/Milk OIT | 3 | 28 | 102 |
| other | Ear Pruritus | Ear and labyrinth disorders | Untreated Control | 0 | 20 | 0 |
| other | Conjunctivitis | Eye disorders | Omalizumab/Milk OIT | 2 | 28 | 2 |
| other | Conjunctivitis | Eye disorders | Placebo for Omalizumab/Milk OIT | 0 | 29 | 0 |
| other | Conjunctivitis | Eye disorders | Untreated Control | 0 | 20 | 0 |
| other | Eye Pruritus | Eye disorders | Omalizumab/Milk OIT | 3 | 27 | 3 |
| other | Eye Pruritus | Eye disorders | Placebo for Omalizumab/Milk OIT | 6 | 28 | 11 |
| other | Eye Pruritus | Eye disorders | Untreated Control | 0 | 20 | 0 |
| other | Ocular hyperaemia | Eye disorders | Omalizumab/Milk OIT | 1 | 27 | 1 |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omalizumab/Milk OIT | ||
| Total, all-cause mortality | Placebo for Omalizumab/Milk OIT | ||
| Total, all-cause mortality | Untreated Control | ||
| Total, other adverse events | Omalizumab/Milk OIT | 26 | 28 |
| Total, other adverse events | Placebo for Omalizumab/Milk OIT | 28 | 29 |
| Total, other adverse events | Untreated Control | 1 | 20 |
| Total, serious adverse events | Omalizumab/Milk OIT | 1 | 28 |
| Total, serious adverse events | Placebo for Omalizumab/Milk OIT | 0 | 29 |
| Total, serious adverse events | Untreated Control | 1 | 20 |
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 |
|---|---|---|---|---|---|
| U19AI044236 | Immunologic Basis of Cow's Milk-Induced Hypersensitivities | SAMPSON, HUGH A | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2008 to 2014 |
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/NCT01157117
GET https://conductscience.org/api/trials/v1/NCT01157117/results?page=2