Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FAI001 | Other Identifier | Jaffe Food Allergy Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. 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 immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat OIT | Active Comparator | Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol. |
|
| Placebo | Placebo Comparator | Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat OIT | Drug | Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment. | Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge | The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group. | 8 to 10 weeks after passing the 2 Year OFC |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hugh A Sampson, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Hugh A Sampson, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Ann & Robert H. Lurie Children's Hospital of Chicago |
Not provided
Enrollment began November 2013 and was completed in November 2014
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then High Dose Group | 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC). |
| FG001 | Wheat OIT | 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 52 Weeks Blinded Study Treatment |
|
| |||||||||||||||||||||
| 52 Weeks Open Label Active Wheat OIT |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then High Dose Group | 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment. | Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment. | All randomized participants were included. | Posted | Count of Participants | Participants | 1 Year |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wheat OIT Before 1 Year | 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hugh A. Sampson | Icahn School of Medicine at Mount Sinai | 212-659-9426 | hugh.sampson@mssm.edu |
Not provided
| ID | Term |
|---|---|
| D021182 | Wheat Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT | The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder. | 44 Weeks |
| Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group | The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint). | 2 Years |
| Incidence of All Serious Adverse Events During the Study. | 1 year and 2 Years |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 100029 | United States |
| Non-compliance |
|
| NOT COMPLETED |
|
|
| BG001 | Wheat OIT | 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Wheat IgE | Amount of serum wheat-specific immunoglobulin E (IgE). Individuals with a wheat IgE of <0.35 kUA/L are considered not to be sensitized to wheat. The limits of detection for the wheat IgE assay were 0.1 to 100 kUA/L. Values below the limit of detection were set to 0.05 kUA/L and those above the limit of detection were set to 101 kUA/L. | Median | Inter-Quartile Range | kUA/L |
|
| Wheat IgG4 | Amount of immunoglobulin G4 (IgG4). The limits of detection for the wheat IgG4 assay were 0.1 to 30 mgA/L. Values below the limit of detection were set to 0.05 mgA/L and those above the limit of detection were set to 31 mgA/L for wheat IgG4. | Median | Inter-Quartile Range | mgA/L |
|
| Wheat Skin Prick Test | This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the wheat wheal (in mm) observed for a skin prick test. Individuals with a wheat skin prick test score of < 3 mm are considered to have a negative result. | Mean | Standard Deviation | mm |
|
| Wheat OFC Dose at First Symptom | Median | Inter-Quartile Range | mg protein |
|
| Wheat OFC Successfully Consumed Dose | Median | Inter-Quartile Range | mg protein |
|
| Maximum Initial Escalation Day Dose | Median | Full Range | mg powder |
|
| OG001 | Wheat OIT | 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC. |
|
|
| Secondary | Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge | The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group. | This is not applicable for the Placebo Crossover subjects as they did not complete at 2 Year Tolerance OFC per the protocol. | Posted | Count of Participants | Participants | 8 to 10 weeks after passing the 2 Year OFC |
|
|
|
| Secondary | Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT | The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder. | Posted | Count of Participants | Participants | 44 Weeks |
|
|
|
| Secondary | Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group | The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint). | Two Placebo subjects did not crossover. This outcome measure is only for the Placebo crossover group. | Posted | Count of Participants | Participants | 2 Years |
|
|
|
| Secondary | Incidence of All Serious Adverse Events During the Study. | Data was available for 22 participants in the Wheat OIT group and 21 participants for the Placebo Crossover group at the end of the study. | Posted | Count of Participants | Participants | 1 year and 2 Years |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 23 |
| 23 |
| EG001 | Placebo Before 1 Year | 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC). | 0 | 23 | 3 | 23 | 21 | 23 |
| EG002 | Wheat OIT After 1 Year | 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC. | 0 | 22 | 1 | 22 | 18 | 22 |
| EG003 | Placebo Crossover | 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC). | 0 | 21 | 1 | 21 | 21 | 21 |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rhinitis allergic | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastrontestinal disorder | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastrooescophageal refluz disease | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Oral mucosal eruption | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| nervousness | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rhimorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Flashing | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided