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| ID | Type | Description | Link |
|---|---|---|---|
| COFAR | |||
| U19AI066738 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Consortium of Food Allergy Research | OTHER |
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The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.
In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time.
This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC).
For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points (approximately Week 96 and annually thereafter) to test for desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg.
Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2 years. These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg.
At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg Oral Immunotherapy (OIT) | Experimental | Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet. |
|
| Control Group | Placebo Comparator | Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg oral immunotherapy | Drug | Egg white solid powder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg | Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes. | At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid | Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes. | Following the blinded desensitization phase at approximately Week 44 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | University of North Carolina | Study Chair |
| Stacie Jones, MD | Allergy/Immunology Department, Arkansas Children's Hospital | Study Chair |
| Robert Wood, MD | Johns Hopkins University | Principal Investigator |
| Scott Sicherer, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| David Fleischer, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16272231 | Background | Baral VR, Hourihane JO. Food allergy in children. Postgrad Med J. 2005 Nov;81(961):693-701. doi: 10.1136/pgmj.2004.030288. | |
| 16455349 | Background | Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. doi: 10.1016/j.jaci.2005.05.048. | |
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| ID | Type | URL | Comment |
|---|---|---|---|
| SDY218 | Individual Participant Data Set | View IPD |
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital) from July 2007 to December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Egg Oral Immunotherapy (OIT) | Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet. |
| FG001 | Placebo | Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Egg Oral Immunotherapy (OIT) | Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet. |
| 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 | Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg | Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes. | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Posted | Number | percentage of participants | At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy |
|
Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
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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 | Egg Oral Immunotherapy (OIT), 0-2 Years | Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA (15.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsgov@niaid.nih.gov |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D005512 | Food Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group |
| Drug |
Placebo for egg white solid |
|
| Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation | On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur. | Initial day of dosing |
| Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg | For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose. | Following the blinded desensitization phase at approximately Week 44 |
| Number of Participants With Serious Adverse Events (SAEs) | This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3. | Baseline through the 2-year primary endpoint |
| Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid | Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment. | 4 years (48 months) |
| National Jewish Medical and Research Center |
| Denver |
| Colorado |
| 80206 |
| United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hills | North Carolina | 27599 | United States |
| 12777603 |
| Background |
| Wood RA. The natural history of food allergy. Pediatrics. 2003 Jun;111(6 Pt 3):1631-7. |
| 22808958 | Result | Burks AW, Jones SM, Wood RA, Fleischer DM, Sicherer SH, Lindblad RW, Stablein D, Henning AK, Vickery BP, Liu AH, Scurlock AM, Shreffler WG, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Oral immunotherapy for treatment of egg allergy in children. N Engl J Med. 2012 Jul 19;367(3):233-43. doi: 10.1056/NEJMoa1200435. |
| 26924470 | Derived | Jones SM, Burks AW, Keet C, Vickery BP, Scurlock AM, Wood RA, Liu AH, Sicherer SH, Henning AK, Lindblad RW, Dawson P, Berin C, Fleischer DM, Leung DYM, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy. J Allergy Clin Immunol. 2016 Apr;137(4):1117-1127.e10. doi: 10.1016/j.jaci.2015.12.1316. Epub 2016 Mar 9. |
ImmPort study identifier is SDY218 |
| SDY218 | Study summary, -design, -adverse events, -demographics,-lab tests,-mechanistic assays, -study files | View IPD | ImmPort study identifier is SDY218 |
| BG001 | Placebo | Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Atopic Dermatitis Total Score | The Atopic Dermatitis Total Score is scored on a 10 point scale from 0 to 9 where a higher score indicates increased severity of atopic dermatitis. This score is a combination of 3 scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity. | Mean | Standard Deviation | Scores on a scale |
|
| Total IgE | Total amount of serum immunoglobulin E. Individuals who are not allergic may have a total IgE as high as 304 kU/L. | Mean | Standard Deviation | kU/L |
|
| Egg IgE | Amount of serum egg-specific immunoglobulin E. Individuals with an egg IgE of <0.35 kUA/L are considered not to be sensitized to egg. | Mean | Standard Deviation | kUA/L |
|
| Egg Skin Prick Test Score | This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the egg wheal (in mm) observed for a skin prick test. Individuals with an egg skin prick test score of < 3 mm are considered to have a negative result. | Mean | Standard Deviation | mm |
|
| Age at Initial Egg Allergic Reaction | Mean | Standard Deviation | years |
|
| OG001 | Placebo | Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption. |
|
|
|
| Secondary | Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid | Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes. | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Posted | Number | percentage of participants | Following the blinded desensitization phase at approximately Week 44 |
|
|
|
| Secondary | Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation | On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur. | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Posted | Number | percentage of participants | Initial day of dosing |
|
|
|
| Secondary | Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg | For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose. | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Posted | Number | percentage of participants | Following the blinded desensitization phase at approximately Week 44 |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3. | The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment. | Posted | Number | participants | Baseline through the 2-year primary endpoint |
|
|
|
| Secondary | Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid | Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment. | Posted | Number | percentage of participants | 4 years (48 months) |
|
|
|
| 3 |
| 40 |
| 40 |
| 40 |
| EG001 | Placebo, 0-2 Years | Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption. | 0 | 15 | 15 | 15 |
| EG002 | Egg Oral Immunotherapy (OIT), 2-4 Years | Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet. Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing). | 1 | 36 | 26 | 36 |
| Respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Tonsillitis streptococcal | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ear pruritus | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Staphylococcal impetigo | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided
Not provided
| D008722 | Methods |