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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI044236 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products.
Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop "tolerance," which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair® (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab/milk OIT | Experimental | Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization oral food challenge (OFC). Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28, participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
|
| Placebo for omalizumab/milk OIT | Placebo Comparator | Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28, participants complete a 10g milk oral food challenge (OFC); if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
|
| Untreated control | No Intervention | Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo for omalizumab | Biological | Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dosing Reactions to Milk OIT During the Escalation Phase | Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase. | Baseline to completion of Escalation Phase at 22 to 40 weeks |
| Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase |
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Inclusion Criteria:
Active Treatment Subjects:
Control Subjects:
• A skin prick test positive to milk (diameter of wheal >= 10.0 mm) OR detectable serum milk specific IgE level within the previous 12 months (UniCAP >= 15 kUA/L)
Exclusion Criteria:
A history of life-threatening anaphylaxis to milk (involving hypotension or requiring mechanical ventilation)
Known allergy to any components of the placebo for Xolair®
Chronic disease other than asthma, atopic dermatitis, or allergic rhinitis requiring therapy (e.g., heart disease, diabetes)
Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), or calcium channel blockers
Severe asthma
Mild or moderate asthma with any of the following criteria met:
Baseline spirometry (or peak flow rate (PFR) if unable to perform spirometry) result of FEV1<80%
Pregnancy or lactation. All females of child-bearing age will undergo pregnancy testing. All treated females will confirm compliance to appropriate birth control measures throughout the course of the study;
Participation in any interventional study for the treatment of food allergy in the past 6 months
Subject is on a buildup phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose);
Use of Xolair® (omalizumab) or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual immunotherapy) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
Inability to discontinue antihistamines for 5 half-lives prior to routine study tests (DBPCMC or endpoint titration tests)
Known sensitivity to Xolair® (omalizumab) or to the class of study drugs
Baseline serum total IgE over 1,300 IU/mL or body weight more than 150 kg, or subjects with weight-IgE combination that yields a dose requirement greater than 750 mg (due to limitations of Xolair® (omalizumab) dosing)
Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements
Inability or unwillingness of a subject to give written informed consent or comply with study protocol
Use of investigational drugs within 90 days of participation
Other contraindications to milk oral immunotherapy or Xolair® (omalizumab)
Recipient of any licensed or investigational live attenuated vaccine(s) within 2 months of enrollment
Families who do not speak English
Systemic steroids oral, intramuscular (IM), or IV for indications other than asthma for greater than 3 weeks in the past 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Hugh A. Sampson, M.D. | Icahn School of Medicine at Mount Sinai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Johns Hopkins University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26581915 | Result | Wood RA, Kim JS, Lindblad R, Nadeau K, Henning AK, Dawson P, Plaut M, Sampson HA. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. J Allergy Clin Immunol. 2016 Apr;137(4):1103-1110.e11. doi: 10.1016/j.jaci.2015.10.005. Epub 2015 Nov 12. | |
| 25609353 | Derived | Noone S, Ross J, Sampson HA, Wang J. Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):424-8. doi: 10.1016/j.jaip.2014.10.008. Epub 2015 Jan 13. |
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Recruitment took place at three university-based medical centers in the United States (Mount Sinai, Johns Hopkins University, Stanford University) beginning in October 2010. Accrual of randomized participants was completed in April 2012 and of untreated controls was completed in August 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab/Milk OIT | Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| FG001 | Placebo for Omalizumab/Milk OIT | Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| FG002 | Untreated Control | Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab/Milk OIT | Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk | 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. | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Posted | Number | Percent of participants | 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 |
|
Adverse Events were reported through the end of the study.
Other [Not Including Serious] Adverse Events in the Untreated Control Arm were reported only in the 72 hours after any study-specific blood draws.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omalizumab/Milk OIT | Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pruritus | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hugh A. Sampson | Ichan School of Medicine at Mount Sinai | 212-659-9426 | hugh.sampson@mssm.edu |
Not provided
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| C057917 | Refit milk powder |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Omalizumab | Biological | Omalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight. |
|
|
| Milk powder | Drug | Milk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed. |
|
Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase. |
| After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30 |
| Incidence of Severe Hypersensitivity Reactions to Milk OIT | Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction. | Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC) |
| Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT) | 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. | Baseline to completion of Escalation Phase at 22 to 40 weeks |
| Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk | 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. | Month 28 |
| Time to Maximum Tolerated Dose | 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. | Baseline to completion of Escalation Phase at 22 to 40 weeks |
| Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test | 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. | Month 32 |
| Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE) | 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. | Month 32 |
| Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4) | 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. | Month 32 |
| Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE) | 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 38 was 6 months after treatment ended at Month 32. | Month 38 |
| Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4) | 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 38 was 6 months after treatment ended at Month 32. | Month 38 |
| Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk | Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment. | Month 32 |
| Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk | Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32. | Month 38 |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Unknown (Pending Final Form Submission) |
|
| BG001 | Placebo for Omalizumab/Milk OIT | Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
| BG002 | Untreated Control | Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Age | Mean | Standard Deviation | years |
|
| Atopic Dermatitis Total Score | The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity. Note: These data were only available for 12 of the 20 Untreated Control participants. | Mean | Standard Deviation | Scores on a scale |
|
| Total IgE | Total amount of serum immunoglobulin E (IgE). | Mean | Standard Deviation | kU/L |
|
| Milk IgE | Amount of serum milk-specific immunoglobulin E (IgE). Individuals with a milk IgE of <0.35 kUA/L (allergen-equivalent kilounits per liter) are considered not to be sensitized to milk. | Mean | Standard Deviation | kUA/L |
|
| Milk Skin Prick Test Score | This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the milk wheal (in mm) observed for a skin prick test. Individuals with a milk skin prick test score of < 3 mm are considered to have a negative result. | Mean | Standard Deviation | mm |
|
| Age at Initial Milk Allergic Reaction | Age in years at the participant's first milk allergic reaction. Note: These data were only available for 14 of the 28 Omalizumab/Milk OIT participants, 19 of the 29 Placebo for Omalizumab/Milk OIT participants, and 14 of the 20 Untreated Control participants. | Mean | Standard Deviation | years |
|
| OG001 | Placebo for Omalizumab/Milk OIT | Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it. |
|
|
|
| Secondary | Incidence of Dosing Reactions to Milk OIT During the Escalation Phase | Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase. | Participants who received any milk OIT dosing during the Escalation Phase. | Posted | Number | percentage of participants | Baseline to completion of Escalation Phase at 22 to 40 weeks |
|
|
|
| Secondary | Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase | Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase. | Participants who received milk OIT dosing during the Maintenance Phase. | Posted | Number | percentage of participants | After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30 |
|
|
|
| Secondary | Incidence of Severe Hypersensitivity Reactions to Milk OIT | Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction. | Participants who received milk OIT dosing. | Posted | Number | percentage of participants | Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC) |
|
|
|
| Secondary | Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT) | 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. | Participants who received any milk OIT dosing | Posted | Mean | Standard Deviation | mg milk powder | Baseline to completion of Escalation Phase at 22 to 40 weeks |
|
|
|
| Secondary | Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk | 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. | Participants who received any study treatment | Posted | Number | percentage of participants | Month 28 |
|
|
|
| Secondary | Time to Maximum Tolerated Dose | 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. | 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. | Posted | Baseline to completion of Escalation Phase at 22 to 40 weeks |
|
|
| Secondary | Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test | 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. | All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed. | Posted | Median | Full Range | units on a scale | Month 32 |
|
|
|
| Secondary | Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE) | 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. | 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. | Posted | Median | Full Range | kUA/L | Month 32 |
|
|
|
| Secondary | Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4) | 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. | 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. | Posted | Median | Full Range | mgA/L | Month 32 |
|
|
|
| Secondary | Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE) | 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 38 was 6 months after treatment ended at Month 32. | All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported. | Posted | Median | Full Range | kUA/L | Month 38 |
|
|
|
| Secondary | Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4) | 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 38 was 6 months after treatment ended at Month 32. | All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported. | Posted | Median | Full Range | mgA/L | Month 38 |
|
|
|
| Secondary | Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk | Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment. | 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. | Posted | Median | Full Range | percentage of CD63+ basophils | Month 32 |
|
|
|
| Secondary | Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk | Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32. | All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported. | Posted | Median | Full Range | percentage of CD63+ basophils | Month 38 |
|
|
|
| 1 |
| 28 |
| 26 |
| 28 |
| EG001 | Placebo for Omalizumab/Milk OIT | Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight). | 0 | 29 | 28 | 29 |
| EG002 | Untreated Control | Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention. | 1 | 20 | 1 | 20 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oral Disorder | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Feeling Abnormal | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
Not provided
Not provided
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Change in Beta-lactoglobulin IgE |
|
|
|
| Change in Beta-lactoglobulin IgE |
|
|
| Change in %CD63+ for 1 µg/mL stimulant |
|
| Change in %CD63+ for 0.1 µg/mL stimulant |
|
| Change in %CD63+ for 0.01 µg/mL stimulant |
|
| Change in %CD63+ for 0.001 µg/mL stimulant |
|
| Change in %CD63+ for 1 µg/mL stimulant |
|
| Change in %CD63+ for 0.1 µg/mL stimulant |
|
| Change in %CD63+ for 0.01 µg/mL stimulant |
|
| Change in %CD63+ for 0.001 µg/mL stimulant |
|